BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3173361 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03624
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 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
    AZ, 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 STATED THAT HE OBTAINED A READING OF 288 MG/DL ON THE AVIVA METER, AND ACCIDENTALLY TOOK 35 UNITS OF NOVOLOG INSULIN INSTEAD OF 35 UNITS OF LANTUS INSULIN. CUSTOMER WAS ABLE TO SELF-TREAT WITH ORANGE JUICE. CUSTOMER'S FRIEND TOOK HIM TO THE HOSPITAL ABOUT AN HOUR LATER. CUSTOMER'S READING ON THE HOSPITAL METER WAS 217 MG/DL. CUSTOMER OBTAINED THE FOLLOWING RESULTS ON THE AVIVA METER, COMPARED TO THE DOCTOR'S METER, WITHIN 10 MINUTES: 238 MG/DL (AVIVA) AND 51 MG/DL (DOCTOR'S METER). THEN, CUSTOMER OBTAINED A RESULT OF 58 MG/DL ON HIS AVIVA WITHIN 10 MINUTES OF THE READING OF 238 MG/DL. CUSTOMER STATED THAT THE DOCTOR SET UP THE IV BUT DID NOT TURN IT ON OR ADMINISTER IT. CUSTOMER WAS TREATED SUGAR CANDY AND SOME "SUGARY STUFFS." CUSTOMER WAS ADMITTED TO THE HOSPITAL, TREATED, AND RELEASED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273135 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491644

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male ASPIRIN| ATENOLOL| LANTUS| LISINOPRIL| NOVOLOG| PLAVIX| SIMVASTATIN| ASPIRIN| PLAVIX| SIMVASTATIN| LANTUS| NOVOLOG| ATENOLOL| LISINOPRIL