BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2071092 · Received April 27, 2011

    Report

    Report Number
    1823260-2011-02287
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE AVIVA SUSPECT DEVICE SYSTEM USED. REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE INFORM SUSPECT DEVICE SYSTEM USED.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A NEONATE RECEIVED THE RESULTS OF 60 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 48 MG/DL AND 49 MG/DL OBTAINED ON THE AVIVA SYSTEM. REPORTER STATED THAT THE NEONATE IS TAKING DIAZOXIDE THREE TIMES A DAY FOR HYPOGLYCEMIA. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303042

    Patients

    Seq Age Sex Outcome Treatment
    1 007 DA DIAZOXIDE (3 TIMES DAILY)