BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEMSTRIP UG 5000K

    MDR report key: 1192092 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07415
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALLER DID NOT PROVIDE WHICH LOT WAS USED. SEE MEDWATCHES FOR POTENTIAL LOTS USED.

    Description of Event or Problem · 1

    CALLER STATES THAT THE CHEMSTRIPS UG/K PRODUCED A NEGATIVE RESULT. CUSTOMER WAS ALSO USING A BLOOD GLUCOSE DEVICE THAT WAS PRODUCING RESULTS OF 11 MMOL/L AND 13 MMOL/L. CUSTOMER CHOSE TO ACT ON THE CHEMSTRIP OUTPUT AND DID NOT PROVIDE THE CUSTOMER WITH INSULIN. CUSTOMER WAS SUBSEQUENTLY TAKEN TO THE HOSPITAL AND TESTED 15 MMOL/L ON THE HOSPITAL DEVICE. CUSTOMER RECEIVED INSULIN WHILE AT THE HOSPITAL. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP UG 5000K URINE TEST STRIPS - NA JIL ROCHE DIAGNOSTICS 28987831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention