BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2192000 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04210
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    REPORTER ALLEGED OBTAINING THE RESULTS OF 439 MG/DL AND 188 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER ALLEGED OBTAINING THE RESULTS OF 88 MG/DL AND 180 MG/DL BACK TO BACK WITHIN 10 MINUTES, ON A SEPARATE DAY, USING THE SAME, AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 303240

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR FUROSEMIDE| GABAPENTIN| NOVOLIN| TRAPEZE BAR| SHOWER CHAIR| 2 WALKERS| BEDSIDE COMMODE| HOSPITAL BED| HYDROCODONE| TRAZODONE| LEVOTHYROXINE| BUPROPION| REGULAR INSULIN| ZETIA