BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3496585 · Received December 3, 2013

    Report

    Report Number
    2183996-2013-02396
    Event Type
    Malfunction
    Date Received
    December 3, 2013
    Date of Event
    October 22, 2013
    Report Date
    August 12, 2025
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    NBW
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    IU MANUALLY REVIEWED THE METERS MEMORY AND OBSERVED THAT THE METERS DISPLAYED BOLUS DATA WAS OUT OF SEQUENCE WITH REFERENCE TO BG DATA. WITHIN THE INFORMATION PROVIDED BY PRODUCT SUPPORT, THEY INDICATED THAT THE METER WAS NOT DESIGNED TO CHANGE THE ORDER OF RECORDS IN THE DIARY AND THEY WILL BE REPRESENTED IN THE DIARY IN THE ORDER THAT THEY WERE LOADED INTO THE METER. THIS BEHAVIOR CAN OCCUR IF THE CUSTOMER PERFORMS ACTIONS ON THE METER BEFORE SYNCHRONIZING TO THE PUMP EVEN IF A PARTICULAR BOLUS WAS DELIVERED WITH THE METER ACTING AS A REMOTE CONTROL FOR THE PUMP. BOLUS DELIVERIES PROGRAMMED USING THE METER AS A REMOTE CONTROL ARE NOT AUTOMATICALLY LOGGED IN THE DIARY. IT WAS CONCLUDED THAT THE METER IS FUNCTIONING AS INTENDED AND THE CUSTOMER WAS USING THE METER AS A REMOTE CONTROL FOR THE PUMP AND PERFORMED BG TESTS AFTERWARD BEFORE SYNCHING THE PUMP TO THE METER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S AVIVA COMBO WAS PROVIDING A BOLUS ADVICE HIGHER THAN NEEDED. THE FOLLOWING ARE THE EXAMPLES GIVEN TAKEN FROM THE DIARY OVER THE LAST 15 DAYS: 1) BG 200, ADVICE BOLUS 5.5U; 2) BG 217, ADVICE BOLUS 7.6U. DURING THE LAST TWO DAYS, AFTER BREAKFAST: FIRST DAY - BG 161, ADVICE BOLUS 6.3U; SECOND DAY - BG 163, ADVICE BOLUS 8.1U. IT WAS REPORTED THAT THE CUSTOMER ENTERED CARBOHYDRATES INTO THE DEVICE TO DETERMINE THE BOLUS CALCULATION. NO INFORMATION IS AVAILABLE AS TO WHAT THE CUSTOMER WAS EATING AT THE TIME OF THE DATA PROVIDED OR WHAT THE CARBOHYDRATE AMOUNTS WERE THAT WERE ENTERED INTO THE DEVICE. IT WAS ALLEGED THAT THE DEVICE HAS BEEN GIVING THE WRONG BOLUS ADVICE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624535 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female