BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2904185 · Received January 9, 2013

    Report

    Report Number
    1823260-2013-00188
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 17, 2012
    Report Date
    February 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH (B)(6) IS AVIVA SYSTEM 1, MEDWATCH WITH (B)(6) IS AVIVA SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING HOSPITALIZATION AT A TIME WHEN AVIVA SYSTEM 1 AND AVIVA SYSTEM 2 WERE UNAVAILABLE FOR USE DUE TO E-1. WIFE ATTEMPTED TO USE BOTH HUSBAND'S METER (AVIVA SYSTEM 1) AND HER OWN METER (AVIVA SYSTEM 2) AT THE SAME TIME DURING HYPOGLYCEMIA EVENT. THE SAME STRIPS WERE USED ON BOTH METERS. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11091 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR Hospitalization 2 CANES| OXYGEN TANK| WALKER| WHEEL CHAIR