BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 15661408 · Received October 24, 2022

    Report

    Report Number
    3004464228-2022-19903
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    October 10, 2022
    Report Date
    October 10, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. "HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755 PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158"

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 CONTROLLER. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP. D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG. CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000408 TO PT-000409. CATALOG NO CHANGED FROM UNAVAILABLE TO SKT-H001-G-X9. UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4). CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K203768.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT HAD BEEN HOSPITALIZED. THE PATIENT REPORTS THERE ARE UNABLE TO CORRECT THEIR BLOOD GLUCOSE LEVELS WITH THEIR PERSONAL DIABETES MANAGER (PDM). IT WAS REPORTED THE PATIENT HAD BEEN SHAKING WHILE IN BED AND HAD A SEIZURE. THE PATIENTS¿ BLOOD GLUCOSE LEVEL HAD DECREASED TO 27 MG/DL. THE PATIENT HAD TAKEN AN AMBULANCE TO THE HOSPITAL. ONCE AT THE HOSPITAL THE PATIENTS POD WAS REMOVED. THE PATIENT WAS DIAGNOSED WITH HYPOGLYCEMIA AND LEUKEMOID REACTION. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF DECTROSE AS WELL AS 8 UNITS 2 TIMES A DAY OF TOUJEO INSULIN AND HUMALOG INSULIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 2 DAYS.B5 - DESCRIBE EVENT OR PROBLEM CHANGED FROM : IT WAS REPORTED THAT A PATIENT HAD BEEN HOSPITALIZED. THE PATIENT REPORTS THERE ARE UNABLE TO CORRECT THEIR BLOOD GLUCOSE LEVELS WITH THEIR PERSONAL DIABETES MANAGER (PDM). NO FURTHER INFORMATION HAS BEEN PROVIDED AS TO THIS EVENT. CHANGED TO: IT WAS REPORTED THAT A PATIENT HAD BEEN HOSPITALIZED. THE PATIENT REPORTS THERE ARE UNABLE TO CORRECT THEIR BLOOD GLUCOSE LEVELS WITH THEIR PERSONAL DIABETES MANAGER (PDM). IT WAS REPORTED THE PATIENT HAD BEEN SHAKING WHILE IN BED AND HAD A SEIZURE. THE PATIENTS¿ BLOOD GLUCOSE LEVEL HAD DECREASED TO 27 MG/DL. THE PATIENT HAD TAKEN AN AMBULANCE TO THE HOSPITAL. ONCE AT THE HOSPITAL THE PATIENTS POD WAS REMOVED. THE PATIENT WAS DIAGNOSED WITH HYPOGLYCEMIA AND LEUKEMOID REACTION. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF DECTROSE AS WELL AS 8 UNITS 2 TIMES A DAY OF TOUJEO INSULIN AND HUMALOG INSULIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 2 DAYS. ADDED TO H6 - ADVERSE EVENT PROBLEM- HEALTH EFFECT - CLINICAL CODE: E1206 HYPOGLYCEMIA. E0109 CONVULSION/SEIZURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD BEEN HOSPITALIZED. THE PATIENT REPORTS THERE ARE UNABLE TO CORRECT THEIR BLOOD GLUCOSE LEVELS WITH THEIR PERSONAL DIABETES MANAGER (PDM). NO FURTHER INFORMATION HAS BEEN PROVIDED AS TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD BEEN HOSPITALIZED. THE PATIENT REPORTS THERE ARE UNABLE TO CORRECT THEIR BLOOD GLUCOSE LEVELS WITH THEIR PERSONAL DIABETES MANAGER (PDM). IT WAS REPORTED THE PATIENT HAD BEEN SHAKING WHILE IN BED AND HAD A SEIZURE. THE PATIENTS¿ BLOOD GLUCOSE LEVEL HAD DECREASED TO 27 MG/DL. THE PATIENT HAD TAKEN AN AMBULANCE TO THE HOSPITAL. ONCE AT THE HOSPITAL THE PATIENTS POD WAS REMOVED. THE PATIENT WAS DIAGNOSED WITH HYPOGLYCEMIA AND LEUKEMOID REACTION. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF DECTROSE AS WELL AS 8 UNITS 2 TIMES A DAY OF TOUJEO INSULIN AND HUMALOG INSULIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2664941 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization