BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3832445 · Received May 27, 2014

    Report

    Report Number
    1823260-2014-03710
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 3, 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
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE STATED THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT ON (B)(6) 2014 AROUND 5:00 P.M. SHE TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 84 MG/DL; HOWEVER, THE CUSTOMER WAS UNRESPONSIVE AND UNABLE TO TREAT HIMSELF. SHE GAVE THE CUSTOMER ORANGE JUICE AND CONTACTED THE PARAMEDICS. THE PARAMEDICS ARRIVED AROUND 5:20 P.M., AND HE WAS TRANSPORTED TO THE HOSPITAL DUE TO SUSPECTED STROKE. HIS BLOOD GLUCOSE MEASUREMENT AT THE HOSPITAL WAS 60 MG/DL AT 6:00 P.M., AND HE WAS TREATED WITH AN IV GLUCOSE SOLUTION. HIS BLOOD GLUCOSE WAS 300 MG/DL AT 7:00 P.M. AND 147 MG/DL AT 8:20 P.M., WHICH WAS PRIOR TO DISCHARGE. THE ALLEGED PRODUCTS WERE REQUESTED FOR EVALUATION; HOWEVER, THE TEST STRIPS ARE NOT AVAILABLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311235 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492165

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male CARVEDILOL 25 MG| HYDROCODONE| ISOSORBIDE MONONITRATE| LANTUS| METFORMIN| NOVOLOG| PANTOPRAZOLE| PRAVASTATIN| TAMSULOSIN| PANTOPRAZOLE| HYDROCODONE| PRAVASTATIN| TAMSULOSIN| METFORMIN| NOVOLOG| LANTUS| ISOSORBIDE MONONITRATE| CARVEDILOL 25 MG