BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4954177 · Received July 22, 2015

    Report

    Report Number
    3004464228-2015-00334
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 8:42; BOLUS (U): 7.7. TIME: 10:26; BG (MMOL/L) (MG/DL): 11.6 209; CHO (G): 26; BOLUS (U) 4.3. TIME: 3:30; BG (MMOL/L) (MG/DL): 4.9 AND 8.7 88 AND 157. TIME: 9:35; BG (MMOL/L) (MG/DL): 8.0 144; CHO (G): 60; BOLUS (U): 7.5. TIME: 1:40; BG (MMOL/L) (MG/DL): 13.4 241; CHO (G): 84; BOLUS (U): 10.5. TIME: 4:10; BG (MMOL/L) (MG/DL): 15.1 272; BOLUS (U): 1.75. TIME: 5:45; BG (MMOL/L) (MG/DL): 15.6 281; CHO (G): 20. BOLUS (U): 7.5. TIME: 7:08; CHO (G): 100; BOLUS (U): 16.65. TIME: 8:24; CHO (G): 50; BOLUS (U): 8.3. TIME: 3:55; BG (MMOL/L) (MG/DL): 15.8 284; BOLUS (U): 5.15. TIME: 8:40; BG (MMOL/L) (MG/DL): 9.4 169. TIME: 10:00; BG (MMOL/L) (MG/DL): 12.1 218; CHO (G): 43; BOLUS (U): 8.9. TIME: 1:00 PM; BG (MMOL/L) (MG/DL): 13.0 234. MANUAL INJECTION WITH AN INSULIN PEN (EXACT DOSAGE WAS NOT PROVIDED). THE POD WAS DEACTIVATED AND SHE NOTICED THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476738 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L41592

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR