BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSET INFUSION SET

    MDR report key: 1413547 · Received July 7, 2009

    Report

    Report Number
    MW5011864
    Event Type
    Injury
    Date Received
    July 7, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 7, 2009
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT USING MEDTRONIC MINIMED PARADIGM INSULIN PUMP WITH QUICKSET INFUSION SET LOT 8200956. PT REPORTS BG 60MG/DL, TREATED WITH 15 GRAMS CARBOHYDRATE, RETESTED PRIOR TO DRIVING AND BG WAS 120MG/DL. APPROXIMATELY 30 MINUTES LATER, HE WRECKED CAR INTO TELEPHONE POLE AND WAS CUT OUT OF VEHICLE. REPORTED BG 35MG/DL. TOTALED VEHICLE, AND HOSPITALIZED. PT SUSTAINED LIFETHREATENING SITUATION: BROKE ARM IN 6 PLACES REQUIRING SURGICAL OPERATION, BRUISED KNEE BONE, CHEST INJURIES. PT DENIES ALCOHOL INTAKE. HE WAS ON DAY 2 OF THIS INFUSION SET. PREVIOUSLY THIS MONTH, SIMILAR INCIDENT REPORTED WHERE BG WAS WNL, AND SHORTLY THEREAFTER HAD UNEXPLAINED SEVERE HYPOGLYCEMIA BG 27MG/DL. MINIMED OVERNIGHTED A NEW INSULIN PUMP TO PT. ON 07/06/09, PROVIDERS ALERTED TO RECALL OF QUICKSET INFUSION SET LOT 8 RECALL. DATES OF USE: 2009. DIAGNOSIS: INSULIN DEPENDENT DIABETES. PT USES NEW INFUSION SET Q 3 DAYS. HAS USED QUICKSET INFUSION SETS SINCE EARLY 2009. UNSURE WHICH LOTS HE HAS HAD PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSET INFUSION SET FOR PARADIGM INSULIN PUMP FPA MEDTRONIC MINIMED 8200956

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| O