BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2221578 · Received August 18, 2011

    Report

    Report Number
    2183996-2011-02297
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REQUESTED ASSISTANCE ADJUSTING HER BASAL RATES DUE TO A SEVERE HYPOGLYCEMIC EVENT EARLIER IN THE MORNING. BLOOD GLUCOSE WAS 34 MG/DL AT 1:00 A.M., AND HER DAUGHTER CALLED THE PARAMEDICS APPROXIMATELY 6 HOURS LATER. SHE DOES NOT KNOW WHAT HER BLOOD GLUCOSE WAS AT THAT TIME, AND IT HAD INCREASED TO 50 MG/DL WHEN THE PARAMEDICS LEFT HER HOUSE. PATIENT RECEIVED TREATMENT OF ORANGE JUICE AND "SOME KIND OF LIQUID." PATIENT HAD A ROUTINE DOCTOR'S APPOINTMENT ON THE DAY OF THE REPORT, AND BASAL RATES WERE ADJUSTED. PATIENT HAD ALSO BEEN EXPERIENCING FREQUENT HYPOGLYCEMIA. THE TIME AND DATE WERE PROGRAMMED CORRECTLY ON THE INFUSION DEVICE, AND THE BASAL RATES WERE ADJUSTED DURING THE CALL. PATIENT DID NOT PRIME THE INFUSION SET WHILE IT WAS ATTACHED TO HER BODY. PATIENT HAD NOT CONSUMED ALCOHOL OR HAD ANY LIFESTYLE CHANGES. PATIENT LAST BOLUSED ON (B)(6) 2011. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR OTHER LIQUIDS. PATIENT WAS UNABLE TO PROVIDE HER TARGET BLOOD GLUCOSE RANGE. NO PRODUCT WAS REQUESTED FOR EVALUATION, AS PATIENT WAS GOING TO CONTINUE TO WORK WITH HER PHYSICIAN TO ADJUST HER BASAL RATES TO INCREASE BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention INSULIN INFUSION SET| INSULIN