BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3892052 · Received June 24, 2014

    Report

    Report Number
    1823260-2014-04631
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 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 Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER WAS VA FACILITY NURSE. REPORTED USING CUSTOMER'S AVIVA METER, VA STRIPS TO GET BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/D, AND 249 MG/DL. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368643 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male ASPART| ASPIRIN| ATENOLOL| CRESTOR| GABAPENTIN| GLARGINE| ISOSORBIDE| NITROGLYCERIN TABLETS| PLAVIX| PROTONIX| ATENOLOL| GLARGINE| ISOSORBIDE| ASPIRIN| PROTONIX| PLAVIX| GABAPENTIN| CRESTOR| NITROGLYCERIN TABLETS| ASPART