BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1730203 · Received June 21, 2010

    Report

    Report Number
    1823260-2010-03651
    Event Type
    Malfunction
    Date Received
    June 21, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER EXPERIENCED ERRATIC CO2 RESULTS FOR MULTIPLE PATIENTS, THE EXACT NUMBER IS UNKNOWN. HE PROVIDED CO2 RESULTS FOR TWO PATIENT SAMPLES: PATIENT 1, INITIAL CO2 RESULT WAS 43.9 MMOL/L. THE SAMPLE REPEATED ON THE SAME ANALYTICAL D MODULE ((B)(4)) GAVE 28.7 MMOL/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT AND WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 2, INITIAL CO2 RESULT WAS ZERO. THE SAMPLE REPEATED ON THE SAME ANALYTICAL D MODULE ((B)(4)) GAVE A NORMAL RESULT, THE EXACT VALUE WAS NOT PROVIDED. THE REPEAT RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT AFFECTED BY THE ISSUE. THE CO2 REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBES WERE MISALIGNED AND WERE HITTING THE RIGHT SIDE OF THE OUTER CUVETTES. HE CHANGED CUVETTES AND PERFORMED A PROBE ADJUSTMENT. THE FIELD SERVICE REPRESENTATIVE ALSO CLEANED THE VACUUM LINES AND VERIFIED ALL RINSE STATION ADJUSTMENTS WERE PROPERLY ALIGNED. THE USER SUCCESSFULLY RAN CO2 CALIBRATION AND QUALITY CONTROL.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 378 MG/DL, 212 MG/DL, 170 MG/DL, AND 153 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302378

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR GLIPIZIDE| METFORMIN