BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1801837 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04863
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CUSTOMER ALLEGED A SIGNIFICANT BILIRUBIN INTERFERENCE WITH THE (B)(4) ACETAMINOPHEN APPLICATION. THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FOR ACETAMINOPHEN ON THE ANALYTICAL P MODULE FOR ONE PATIENT SAMPLE COLLECTED FROM A TRANSPLANT PATIENT. THE DATE OF OCCURRENCE WAS NOT PROVIDED. THE INITIAL RESULT FOR ACETAMINOPHEN WAS 130 UMOL/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE BILIRUBIN CONCENTRATION FOR THIS SAMPLE WAS ABOUT 300 UMOL/L. A URINE SAMPLE OBTAINED FROM THE PATIENT WAS TESTED BY (B)(6) AND NO ACETAMINOPHEN WAS DETECTED IN THIS URINE SAMPLE. THE PATIENT WAS TREATED WITH (NAC) N-ACETYL CYSTEINE DUE TO THE QUESTIONABLE ACETAMINOPHEN RESULT OF 130 UMOL/L. NO ADVERSE EVENT HAS BEEN ALLEGED REAGARDING THIS EVENT. THE ACETAMINOPHEN REAGENT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 281 MG/DL AT 5:05PM, 217 MG/DL A HALF MINUTE LATER, 110 MG/DL A FEW SECONDS LATER, AND 135 MG/DL A FEW SECONDS LATER ON THE ACCU-CHEK SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 301983

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR LEVEMIR| NOVOLOG