BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3011256 · Received March 19, 2013

    Report

    Report Number
    1823260-2013-01651
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 11, 2013
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER CAREGIVERS
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 385 MG/DL AND 154 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113811 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female ABILIFY| ARIMIDEX| CYMBALTA| HUMALOG /1XDAY| LEVITRA| LUNESTA| METOPROLOL| PLAVIX| SIMVASTATIN| SINEMET| ABILIFY| LEVITRA| CYMBALTA| METOPROLOL| SINEMET| HUMALOG /1XDAY| ARIMIDEX| PLAVIX| SIMVASTATIN| LUNESTA