BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SENSOR

    MDR report key: 1083503 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05831
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 6, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    CALLER STATES A PT REC'D BLOOD GLUCOSE RESULT OF 15 MMOL/L OBTAINED ON THE ADVANTAGE SYS. CALLER STATES THE CAP OF THE VIAL FOR THE TEST STRIPS HAD BEEN MISPLACED SEVERAL DAYS PRIOR (PER PRODUCT LABELING, IT IS ADVISED TO STORE TEST TRIPS IN ORIGINAL CONTAINER WITH CAP ON, OTHERWISE STRIPS CAN GET DAMP AND MAY GIVE A WRONG RESULT). THE PT WAS TREATED WITH AN UNK AMOUNT OF "ORDINARY INSULIN" BY AUTOMATIC SYRINGE BASED ON THE RESULT OF 15 MMOL/L. THE PT REPORTEDLY EXPERIENCED SEVERE HYPOGLYCEMIA WITH LAB VALUE OF 0.89 MMOL/L (TIMEFRAME BETWEEN RESULT OF 15 MMOL/L AND HYPOGLYCEMIA IS NOT KNOWN; THE LAB HAD BEEN DRAWN AT 18:30 AND REPORTED TO THE CALLER AT 10:15). PT'S INSULIN WAS STOPPED AND "SUGARING" WAS ADMINISTERED. PT RECOVERED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SENSOR BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 449976

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention