BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3911912 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04869
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    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
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: MEDWATCH (B)(6) - AVIVA PLUS STRIPS LOT # 491641; MEDWATCH (B)(6) - AVIVA PLUS STRIPS LOT # 493594. THIS MEDWATCH IS FOR AVIVA PLUS STRIPS LOT # 493594.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: WITH STRIP LOT 491641, 95 MG/DL AND 323 MG/DL AND WITH STRIP LOT 493594, 96 MG/DL, 377 MG/DL, AND 291 MG/DL. NO DEATH OR SERIOUS INJURY REPORTED. THERE ARE NO REMAINING STRIPS TO RETURN FROM LOT 491641. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389400 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493594

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male ASPIRIN| CIMETIDINE| GLARGINE| IBUPROFEN| LEG BRACE WITH A LIFT| LISINOPRIL| METFORMIN| METOPROLOL TARTRATE| RUGBY STOOL SOFTENER| SIMVASTATIN| VITAMIN C| VITAMIN D| VITAMIN E| IBUPROFEN| SIMVASTATIN| LEG BRACE WITH A LIFT| VITAMIN C| LISINOPRIL| METFORMIN| METOPROLOL TARTRATE| CIMETIDINE| VITAMIN D| RUGBY STOOL SOFTENER| GLARGINE| VITAMIN E| ASPIRIN