BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2981201 · Received February 27, 2013

    Report

    Report Number
    1823260-2013-01193
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 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
    FL, 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 REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 157 MG/DL AND 53 MG/DL WITHIN 10 MINUTES. SHE STATES THAT AFTER THE READING OF 53, SHE BELIEVES SHE TOOK TWO GLUCOSE TABLETS, BUT CAN'T REMEMBER EXACTLY WHAT SHE TOOK. HER BLOOD SUGAR READINGS WENT UP AFTER THE GLUCOSE TABS AND SHE HAS BEEN FEELING FINE SINCE. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83596 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491328

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female LANTUS| LEVOTHYROXINE| LIPITOR| METHADONE| NEXIUM| NORTRIPTYLINE| NOVOLOG| PERCOCET| RAPAFLO| SOMA| TEMAZEPAM| XANAX| RAPAFLO| XANAX| METHADONE| PERCOCET| SOMA| LIPITOR| NORTRIPTYLINE| TEMAZEPAM| LEVOTHYROXINE| LANTUS| NOVOLOG| NEXIUM