BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1961372 · Received January 14, 2011

    Report

    Report Number
    1823260-2011-00248
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    July 7, 2010
    Report Date
    January 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 271 MG/DL AND 112 MG/DL. CUSTOMER STATED THAT HE DID NOT WASH HIS HANDS PRIOR TO THE 271 MG/DL RESULT. CUSTOMER THOUGHT THE RESULT WAS INCORRECT, SO HE WASHED HIS HANDS AND THEN OBTAINED THE RESULT OF 112 MG/DL. CUSTOMER STATED THAT HE MAY HAVE HAD ALCOHOL ON HIS HANDS AT THE TIME OF THE READINGS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, STRIPS HAVE BEEN DISCARDED. REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR BLOOD PRESSURE MACHINE| GENERIC FLONASE| METFORMIN| "ETODOLACT"| UNKNOWN INSULIN 70/30| BABY ASPIRIN| HYDROCHLOROTHIAZIDE| SIMVASTATIN| LORATADINE