BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2933516 · Received January 29, 2013

    Report

    Report Number
    1823260-2013-00508
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 10, 2013
    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
    OH, 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 88 MG/DL AND 55 MG/DL. CUSTOMER HAD HYPOGLYCEMIC SYMPTOM OF SWEATING WITH THE READINGS. CUSTOMER SELF-TREATED WITH A GLUCOSE TABLET AND A FULL GLASS OF MILK. CUSTOMER FELT BETTER IN 30 MINUTES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39126 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491300

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male HUMULIN N| HUMULIN R| PACEMAKER| HUMULIN R| HUMULIN N| PACEMAKER