BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSTRIP

    MDR report key: 3424231 · Received September 12, 2013

    Report

    Report Number
    3424231
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    August 22, 2013
    Report Date
    September 12, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    FCO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AN ASSESSMENT WAS DONE OF METERS THROUGHOUT THE FACILITY. IT WAS NOTED THAT 14 OF THE 27 METERS HAD BATTERIES THAT WERE BULGING AND WOULD NOT ALLOW THE DOOR TO CLOSE PROPERLY ON THE METER. A NOVA CLINICAL SPECIALIST HELPED THE FACILITY IDENTIFY THIS PROBLEM. ALL OF THE BATTERIES ARE SUPPLIED THROUGH NOVA BIOMEDICAL, HOWEVER, THEY ARE MANUFACTURED BY FORMOSA ELECTRONIC INDUSTRIES, INC. (RECHARGEABLE LI-POLYMER BATTERY PACK, DC 3.7V). ALSO, THE FACILITY USES ANOTHER BATTERY MANUFACTURED BY A&S ENERGY CO., LTD. (MODEL AS2001, DC 3.7V, EXPIRATION DATE 11/13) HOWEVER THESE BATTERIES DO NOT BULGE AT ALL. WHEN THE METERS WERE FIRST IMPLEMENTED IN SPRING OF 2013, NOVA DID NOT INFORM THE FACILITY THAT THERE HAD BEEN PROBLEMS WITH THE BATTERIES AND THAT THE BATTERIES HAVE EXPIRATION DATES. ALSO OF NOTE IS THAT THE METERS WITH SWOLLEN BATTERIES SHOW THE LIGHTS ON THE RIGHT SIDE OF THE DOCKING STATION TO BE AMBER IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458968 NOVA STATSTRIP GLUCOSE METER, BATTERY FCO NOVA BIOMEDICAL CORP. AS2001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NOVA STASTSTRIP GLUCOSE METERS