BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SENSOR COMFORT TEST STRIPS

    MDR report key: 1002484 · Received February 25, 2008

    Report

    Report Number
    1823260-2008-01813
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT EXPERIENCED HYPOGLYCEMIA COINCIDENT WITH EXTRANEAL THERAPY (A LABELED INTERFERENT FOR THE TEST STRIPS). REPORTER INDICATED THAT PATIENT'S BLOOD GLUCOSE RESULTS, ON THE INFORM SYSTEM WERE CONSISTENTLY ELEVATED (ACTUAL VALUES WERE NOT PROVIDED). BASED ON THESE VALUES, A PHYSICIAN REPORTEDLY TREATED PATIENT WITH INSULIN (AMOUNT AND TYPE NOT PROVIDED). AN UNSPECIFIED TIME LATER, PATIENT BECAME HYPOGLYCEMIC. PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED, ON AN UNSPECIFIED INSTRUMENT, WITH A RESULT OF 15 MG/DL; THE INFORM SYSTEM MEASURED PATIENT'S BLOOD GLUCOSE AT 280 MG/DL. REPORTER INDICATED THAT PATIENT SUBSEQUENTLY RECOVERED FROM HYPOGLYCEMIC EVENT. HOWEVER, NO DETAILS OF TREATMENT RECEIVED WERE PROVIDED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention EXTRANEAL