BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1111678 · Received August 13, 2008

    Report

    Report Number
    1823260-2008-06173
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 19, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 12 MG/DL ON A PATIENT USING THE INFORM SYSTEM AND THE PATIENT WAS GIVEN 2 AMPULES OF D50. REPORTER ALLEGED WITHIN 10 MINUTES OF THE 12 MG/DL RESULT ON THE INFORM, A RESULT OF 27 MG/DL WAS OBTAINED ON THE LAB. REPORTER STATED THAT WITHIN ANOTHER 10 MINUTES OF THE LAD RESULT, DISCREPANT BLOOD GLUCOSE RESULT OF 420 MG/DL AND 452 MG/DL WERE OBTAINED ON THE INFORM SYSTEM. REPORTER STATED THAT THE PATIENT WAS THEN GIVEN 7 UNITS OF NOVOLOG. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER STATED THAT SHE IS UNABLE TO RETURN THE STRIPS, AND SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK AMLOPIDINE| ACETAMINOPHEN| PANTOPRAZOLE| LABETALOL| MINOXIDIL| CLONIDINE| SIMVASTATIN| FLUOXETINE| ASPIRIN| ZIPRASIDONE