BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3181738 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08721
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/17/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. NO DATA WAS FOUND IN THE BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED INADVERTENT INFUSION DUE TO CONTINUED USE. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. MOISTURE DAMAGE WAS OBSERVED IN BATTERY COMPARTMENT. A LEAK TEST DETERMINED THAT THE BATTERY COMPARTMENT WAS FOUND TO BE LEAKING. THE PUMP WAS OPENED AND INTERNAL MOISTURE DAMAGE WAS FOUND ON PRINTED CIRCUIT BOARD (PCB). ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING HE EXPERIENCED LOW BLOOD GLUCOSE (BG) AND WAS INCOHERENT AND WAS UNABLE TO REMEMBER WHAT HIS BG READING WAS. THE PATIENT REPORTEDLY WAS CLOSE TO CALLING THE AMBULANCE BUT WAS TREATED WITH ORAL CARBOHYDRATES AND HIS BG READING WENT UP TO 4.9MMOL/L. THE PATIENT CLAIMED HE INADVERTENTLY BOLUSED 23 UNITS OF INSULIN VIA THE PUMP WHILE STILL CONNECTED DURING ASLEEP AND DID NOT REALIZE IT. THE PATIENT¿S BG REPORTEDLY WAS IN THE NORMAL RANGE OF 6 MMOL/L TO 7MMOL/L AT THE TIME OF THE CALL WITH CUSTOMER SUPPORT (CS). CS INSTRUCTED THE PATIENT ON HOW TO USE THE SUSPEND FEATURE ON THE PUMP TO PREVENT INADVERTENT INFUSION. THE ISSUE REPORTEDLY WAS RESOLVED AND THE PUMP IS NOT BEING RETURNED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CAUSED THE REPORTED EVENT BECAUSE THE PATIENT HAD INADVERTENTLY DELIVERED INSULIN WHILE STILL CONNECTED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282147 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening