BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1781526 · Received August 3, 2010

    Report

    Report Number
    1823260-2010-04576
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE AVIVA 525 SYSTEM. REFERENCE MEDWATCH WITH (B)(4) FOR AVIVA 535 SYSTEM.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) REGARDING A (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS PATIENT. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2010, A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE PERITONEAL ANALYSIS AND CULTURE RESULTS WERE UNKNOWN. ON (B)(6) 2010, THE PATIENT BEGAN ANTIBIOTIC THERAPY WITH REFLIN AND TOBRAMYCIN. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE PATIENT'S MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD), HYPERTENSION AND DIABETES. NO CONCOMITANT MEDICATIONS WERE REPORTED. NO STATEMENT OF CAUSALITY WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA 525 SYSTEM WITHIN 2 MINUTES: 280 MG/DL, 175 MG/DL, AND 94 MG/DL. CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 280 MG/DL (AVIVA 525) AND 87 MG/DL (AVIVA 535). 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 302399

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR DIOTIAZEM| COUMADIN| NOVOLOG| BLOOD PRESSURE MONITOR| CARVELOG| METFORMIN| FUROSEMIDE| ASPIRIN| DIGOXIN