PMID- 35771027
OWN - NLM
STAT- MEDLINE
DCOM- 20240102
LR  - 20240423
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 18
IP  - 1
DP  - 2024 Jan
TI  - Insulin Pump-Associated Adverse Events in a Brazilian Reference Center for the 
      Treatment of Diabetes Mellitus: Proposal for a Taxonomy of Device Failures in 
      Adults, Adolescents, and Children.
PG  - 74-81
LID - 10.1177/19322968221106196 [doi]
AB  - BACKGROUND: Since the introduction of continuous subcutaneous insulin infusion 
      (CSII), the benefits have been numerous. However, adverse events (AEs) are 
      experienced by up to 40% of users per year, exposing them to potentially fatal 
      risks. The available evidence on the variables that trigger AEs associated with 
      CSII remains limited, indicating the importance of studies on the subject. AIM: 
      To propose a taxonomy based on the prevalent AEs experienced by patients from a 
      reference diabetes mellitus (DM) center in Brazil using different CSII devices. 
      METHODS: 118 patients participated in an online interview and answered the 
      questions of the data collection instrument. Identifying categories and 
      subcategories of analysis contributed to constructing the AEs taxonomy. RESULTS: 
      The five analysis categories identified were: CSII User Interface (n = 45), CSII 
      Alert System (n = 13), CSII Software and Connection (n = 11), CSII Durability (n 
      = 30), and Electrical and Mechanical System of CSII (n = 60) A total of 159 AEs 
      were identified, including conflicting alert messages and error/warning 
      notification failures, errors resulting from engine malfunctions, data loss, 
      patient interface deficiencies, button problems, and battery failure. 
      CONCLUSIONS: The study describes in a taxonomic format the AEs directly 
      associated with the use of modern CSIIs that may contribute with additional 
      information to the Food and Drug Administration (FDA) Medical Device Report (MDR) 
      adverse event codes. In addition to guiding educational actions in the treatment 
      of DM and providing information for health professionals and medical device 
      developers, prospective studies examining the frequency of such problems, 
      including the potential psychosocial impact of this technologically advanced 
      therapy, are needed.
FAU - Neves, Ana Lucia Domingues
AU  - Neves ALD
AUID- ORCID: 0000-0001-5172-0428
AD  - Postgraduate Program in Translational Medicine, Department of Medicine, Paulista 
      School of Medicine, Federal University of Sao Paulo, Sao Paulo/SP, Brazil.
FAU - Martins, Luiz Eduardo Galvao
AU  - Martins LEG
AD  - Institute of Science and Technology, Federal University of Sao Paulo, Sao 
      Paulo/SP, Brazil.
FAU - Gabbay, Monica Andrade Lima
AU  - Gabbay MAL
AD  - Department of Medicine, Paulista School of Medicine, Federal University of Sao 
      Paulo, Sao Paulo/SP, Brazil.
FAU - Cavicchioli, Gabriela
AU  - Cavicchioli G
AD  - Ambulatory of Insulin Infusion Pump from the Federal University of Sao Paulo 
      Diabetes Center, Sao Paulo/SP, Brazil.
FAU - Tenorio, Fernanda Silva
AU  - Tenorio FS
AD  - Postgraduate Program in Translational Medicine, Department of Medicine, Paulista 
      School of Medicine, Federal University of Sao Paulo, Sao Paulo/SP, Brazil.
FAU - Cunha, Tatiana Sousa
AU  - Cunha TS
AUID- ORCID: 0000-0001-9070-1414
AD  - Institute of Science and Technology, Federal University of Sao Paulo, Sao 
      Paulo/SP, Brazil.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220630
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Child
MH  - Adult
MH  - Humans
MH  - Adolescent
MH  - *Hypoglycemic Agents
MH  - *Diabetes Mellitus, Type 1/drug therapy/psychology
MH  - Brazil/epidemiology
MH  - Prospective Studies
MH  - Insulin
MH  - Injections, Subcutaneous
MH  - Insulin Infusion Systems/adverse effects
MH  - Equipment Failure
PMC - PMC10899856
OTO - NOTNLM
OT  - continuous subcutaneous insulin infusion
OT  - insulin infusion systems
OT  - safety
OT  - taxonomy
OT  - technology
OT  - type 1 diabetes mellitus
COIS- Declaration of Conflicting InterestsThe author(s) declared no potential conflicts 
      of interest with respect to the research, authorship, and/or publication of this 
      article.
EDAT- 2022/07/01 06:00
MHDA- 2024/01/02 11:42
PMCR- 2023/06/30
CRDT- 2022/06/30 09:13
PHST- 2024/01/02 11:42 [medline]
PHST- 2022/07/01 06:00 [pubmed]
PHST- 2022/06/30 09:13 [entrez]
PHST- 2023/06/30 00:00 [pmc-release]
AID - 10.1177_19322968221106196 [pii]
AID - 10.1177/19322968221106196 [doi]
PST - ppublish
SO  - J Diabetes Sci Technol. 2024 Jan;18(1):74-81. doi: 10.1177/19322968221106196. 
      Epub 2022 Jun 30.