BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4192664 · Received October 22, 2014

    Report

    Report Number
    1823260-2014-08147
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 10, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN AVIVA METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 147 MG/DL - PATIENT'S AVIVA METER AND HI (OVER 600 MG/DL) - PARAMEDIC'S METER. THE PATIENT HAD A RESULT OF 121 MG/DL ABOUT 1 HOUR AND 5 MINUTES BEFORE PARAMEDICS WERE CALLED. THE PATIENT DID NOT TAKE ANY TREATMENT BASED ON THE RESULT OF 121 MG/DL. THE PATIENT EXPERIENCED CHEST PAINS AND HER HUSBAND CALLED FOR PARAMEDICS. SHE WAS TREATED WITH INSULIN AND TAKEN TO THE HOSPITAL WHERE SHE WAS AGAIN TREATED WITH INSULIN. SHE WAS KEPT IN THE HOSPITAL FOR 6 DAYS. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673323 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492547

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female CPAP MACHINE| NOVOLIN - UNKNOWN TYPE| SHOWER STOOL| WALKER| WALKING CANE| WHEELCHAIR| WALKING CANE| SHOWER STOOL| NOVOLIN - UNKNOWN TYPE| CPAP MACHINE| WHEELCHAIR| WALKER