BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2171079 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01954
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT SHE WAS HOSPITALIZED ON (B)(6) 2011 DUE TO HYPERGLYCEMIA. BLOOD GLUCOSE WAS 288 MG/DL WHEN SHE WOKE, AND SHE BOLUSED 3 UNITS OF INSULIN. BLOOD GLUCOSE WAS 555 MG/DL AT 4:17 PM AND SHE BOLUSED 6.5 UNITS OF INSULIN. PT FELT "REALLY BAD" AND DROVE TO THE EMERGENCY ROOM. BLOOD GLUCOSE REGISTERED AS "HI" MG/DL ON THE BLOOD GLUCOSE METER. HOSPITAL DELIVERED INSULIN INJECTIONS TO DECREASE BLOOD GLUCOSE TO 600 MG/DL, AND PT WAS HOSPITALIZED FOR 24 HOURS. WHEN PT GOT HOME ON (B)(6) 2011, SHE ATTEMPTED TO BOLUS AND NOTICED THE CARTRIDGE WAS COMPLETELY EMPTY. PT REPORTED THAT SHE DID NOT USE ALL OF THE INSULIN, AND THERE WERE STILL MOISTURE DROPS IN THE CARTRIDGE FROM WHEN IT WAS FILLED. THERE WAS NO INSULIN LEAKAGE THAT PT COULD SEE. INFUSION DEVICE DID NOT DISPLAY A1 LOW CARTRIDGE ALERT OR E1 CARTRIDGE EMPTY ERROR. PT WAS UNABLE TO CONFIRM IF THE INFUSION DEVICE VOLUME INDICATOR READ 0. THE INFUSION NEEDLE IS CHARGED EVERY 4 DAYS AND THE TUBING EVERY 3 WEEKS. PT WAS ADVISED ON MFR RECOMMENDATIONS. BLOOD GLUCOSE WAS 96 MG/DL ON THE DAY OF THE REPORT, AND NORMAL BLOOD GLUCOSE IS 190 MG/DL. INFUSION DEVICE, INFUSION SET, AND CARTRIDGE WERE REPLACED AND REQUESTED FOR EVAL.

    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 66 YR Hospitalization| R INSULIN (DATE OF TX (B)(6))| INSULIN INFUSION SET(DATE OF TX (B)(6))