BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2933610 · Received January 29, 2013

    Report

    Report Number
    1823260-2013-00511
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 6, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT WAS TESTED AT 97 MG/DL ON THE INFORM SYSTEM AT 1139. AT 1157, THE PATIENT WAS TESTED AT 104 MG/DL ON THE INFORM SYSTEM. AT 1208, THE PATIENT BECAME UNRESPONSIVE. A LAB DRAW WAS IMMEDIATELY PERFORMED; HOWEVER, THE LAB RESULT WAS NOT RECEIVED UNTIL 1300. THE LAB RESULT WAS 37 MG/DL. UPON RECEIPT OF THE LAB RESULT, THE PATIENT WAS TREATED WITH DEXTROSE. CALLER STATES THAT THE STAFF DID WITHHOLD TREATMENT TO THE PATIENT BASED UPON THE METER RESULTS. PATIENT WAS ABLE TO FEEL BETTER SOON AFTER TREATMENT WITH DEXTROSE. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39153 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551844

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR Hospitalization| R CLOPIDOGREL| ISOPHANE| ASPIRIN| DEXTROSE