BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2232499 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02305
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 4, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE U.S. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION DEVICE HAS NOT CORRECTLY DISPLAYED E4 OCCLUSION ERRORS OVER THE PAST 4-6 WEEKS. PT WAS ALSO IN A CAR ACCIDENT DUE TO SEVERE HYPOGLYCEMIA ON (B)(6) 2011. BLOOD GLUCOSE WAS 364 MG/DL AT 5:40 AM ON (B)(6) 2011. HE ATE 0.5 KE AND ADMINISTERED 7.5 IU VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 348 MG/DL AT 6:30 AM, AND HE ATE 3 KE AND ADMINISTERED 6 IU VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 288 MG/DL AT 7:00 AM, AND HE ATE 3 KE AND ADMINISTERED 6 IU VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 76 MG/DL AT 11:00 AM, AND HE ATE 3 KE AND ADMINISTERED 5 IU VIA THE INFUSION DEVICE. PT THEN HAD A CAR ACCIDENT AT 2:00 PM. HE WAS UNCONSCIOUS AND WOKE UP IN AN AMBULANCE. HE WAS TRANSPORTED TO THE HOSP AND RECEIVED A GLUCOSE INFUSION BY AN EMERGENCY DOCTOR. BLOOD GLUCOSE WAS 20 MG/DL. PT WAS DISCHARGED FROM THE HOSP AT 6:00 PM THE SAME DAY. THE CARTRIDGE IS NOT REUSED AND IS CHANGED EVERY 4-5 DAYS. INFUSION SET IS CHANGED EVERY 2 DAYS. THE CORRECT TYPE OF BATTERY IS USED IN THE INFUSION DEVICE AND THE BATTERY SETTING IS PROGRAMMED CORRECTLY. PT DID NOT HAVE AN INFECTION OR START NEW MEDICATION. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. NORMAL BLOOD GLUCOSE IS 120 MG/DL. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R INSULIN| INSULIN INFUSION SET