BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3853009 · Received June 6, 2014

    Report

    Report Number
    1823260-2014-04108
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 21, 2014
    Report Date
    August 12, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE BLOOD GLUCOSE MONITOR PROVIDED INCORRECT BOLUS ADVICE. THE CUSTOMER'S BLOOD GLUCOSE WAS 3.3 MMOL/L AT 12:20 P.M., AND SHE DID NOT EAT OR DELIVER INSULIN. SHE ATE 80 GRAMS OF CARBOHYDRATES AT LUNCH AND DID NOT ENTER A BLOOD GLUCOSE VALUE, AND THE MONITOR RECOMMENDED A BOLUS OF 18.0 UNITS OF INSULIN. SHE DELIVERED THE BOLUS AND EXPERIENCED HYPOGLYCEMIA THE REST OF THE DAY. BASED ON THE PROGRAMMING, THE BOLUS RECOMMENDATION SHOULD HAVE BEEN 6.7 UNITS. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333091 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female