PMID- 36724310
OWN - NLM
STAT- MEDLINE
DCOM- 20230510
LR  - 20230522
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 25
IP  - 5
DP  - 2023 May
TI  - Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of 
      Clinical Consequences and Potential Root Causes.
PG  - 343-355
LID - 10.1089/dia.2022.0498 [doi]
AB  - Objective: To explore the clinical consequences and potential root causes of 
      insulin pump-associated adverse events (AEs) reported in the Food and Drug 
      Administration's Manufacturer and User Facility Device Experience (MAUDE) 
      database. Research Design and Methods: Qualitative template analysis of narrative 
      data in a 20% stratified random sample (n = 2429) of reported AEs that occurred 
      during the first 6 months of 2020 involving five insulin pump models marketed at 
      that time: (1) MiniMed 670G, (2) MiniMed 630G, (3) Omnipod((R)), (4) Omnipod 
      DASH((R)), and (5) t:slim X2. Results: Of the 2429 AEs, 92% included a clinical 
      consequence in the narrative description, with critical hyperglycemia (i.e., 
      blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG 
      <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE 
      narratives included information to support the identification of a root cause. 
      The most cited root cause informing remarks were issues with the pump or pod 
      reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), 
      and problems with the infusion set or site (8%). Some clinical consequences and 
      root cause informing remarks were cited more frequently in AE narratives 
      involving specific insulin pump models, but manufacturer variability in the 
      amount and type of information reported may have affected these findings. 
      Conclusions: Our findings show general themes found in insulin pump-associated AE 
      that providers can use to raise patient awareness of potential risks associated 
      with insulin pump use and develop strategies to prevent future AEs. Improvements 
      in AE investigation and reporting processes are still necessary.
FAU - Estock, Jamie L
AU  - Estock JL
AUID- ORCID: 0000-0001-8279-2811
AD  - Office of Research and Development; Pittsburgh, Pennsylvania, USA.
AD  - Center for Health Equity Research and Promotion; Pittsburgh, Pennsylvania, USA.
FAU - Codario, Ronald A
AU  - Codario RA
AD  - Department of Endocrinology; VA Pittsburgh Healthcare System, Pittsburgh, 
      Pennsylvania, USA.
AD  - Division of Endocrinology & Metabolism, Department of Medicine, University of 
      Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
FAU - Keddem, Shimrit
AU  - Keddem S
AD  - Center for Health Equity Research and Promotion, Corporal Michael J. Crescenz VA 
      Medical Center, Philadelphia, Pennsylvania, USA.
AD  - Department of Family Medicine & Community Health, Perelman School of Medicine, 
      University of Pennsylvania, Philadelphia, Pennsylvania, USA.
FAU - Zupa, Margaret F
AU  - Zupa MF
AD  - Center for Health Equity Research and Promotion; Pittsburgh, Pennsylvania, USA.
AD  - Division of Endocrinology & Metabolism, Department of Medicine, University of 
      Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
FAU - Rodriguez, Keri L
AU  - Rodriguez KL
AUID- ORCID: 0000-0002-1477-3659
AD  - Center for Health Equity Research and Promotion; Pittsburgh, Pennsylvania, USA.
FAU - DiNardo, Monica M
AU  - DiNardo MM
AD  - Center for Health Equity Research and Promotion; Pittsburgh, Pennsylvania, USA.
LA  - eng
GR  - I01 HX003581/HX/HSRD VA/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230303
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Insulin)
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - Humans
MH  - Insulin/adverse effects
MH  - *Hypoglycemia/chemically induced/epidemiology/complications
MH  - Blood Glucose/analysis
MH  - *Hyperglycemia/drug therapy
MH  - Insulin Infusion Systems/adverse effects
MH  - *Diabetes Mellitus, Type 1/drug therapy
MH  - Hypoglycemic Agents/adverse effects
OTO - NOTNLM
OT  - Diabetes device safety
OT  - Insulin pump
OT  - Insulin pump adverse events
OT  - Insulin pump injuries
OT  - Insulin pump safety
EDAT- 2023/02/02 06:00
MHDA- 2023/05/10 06:42
CRDT- 2023/02/01 14:33
PHST- 2023/05/10 06:42 [medline]
PHST- 2023/02/02 06:00 [pubmed]
PHST- 2023/02/01 14:33 [entrez]
AID - 10.1089/dia.2022.0498 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2023 May;25(5):343-355. doi: 10.1089/dia.2022.0498. Epub 
      2023 Mar 3.