BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 2648526 · Received July 10, 2012

    Report

    Report Number
    1832816-2012-00068
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    June 18, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION CONFIRM METER WAS GIVING HIGH READINGS. HE HAD READINGS OF 549/222/237/312 AND TREATED WITH 10 UNITS OF INSULIN. CONTROL SOLUTION TEST WAS OUT OF RANGE. I EXPLAINED THE PROPER STORAGE TECHNIQUES FOR THE STRIPS. HE DID MENTION THAT HE WAS STILL FEELING UNEASY AND NOT COMPLETELY NORMAL. HE ALSO STATED THAT HE WAS VERY CONCERNED ABOUT HIS READINGS BECAUSE THEY ARE NOT USUALLY THAT HIGH. I TOLD HIM I WAS GOING TO REPLACE THE METER AND THE STRIPS AND HE WAS GOING TO RECEIVE THEM BY (B)(6). I ALSO TOLD HIM I WILL SEND A CONTROL SOLUTION BOTTLE SO HE CAN DO A TEST EVERY TIME HE THINKS HE IS NOT GETTING ACCURATE READINGS AND EVERY TIME HE OPENS A NEW BOTTLE OF STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712002 B125A10

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening