BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3142341 · Received June 3, 2013

    Report

    Report Number
    1832816-2013-00043
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARKRAY ATTEMPTED TO GATHER INFORMATION AND REQUEST THE RETURN OF SUBJECT METER. ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING AND LOT NUMBER IS NOT KNOWN SO RETENTION SAMPLES COULD NOT BE TESTED. IF EITHER STRIPS OR METER IS RETURNED, ARKRAY WILL EVALUATE THE PRODUCT AND FILE A FOLLOW-UP REPORT. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME METER WAS READING HIGH. ON (B)(6) 2013 THE CUSTOMER CALLED BECAUSE THE AMBULANCE HAD JUST LEFT AND STATED THE PRIME METER READ 100 POINTS DIFFERENT THAN THE EMT METER. INITIALLY STATED PRIME READ 32 AND EMT READ 134, BUT CALLER LATER CHANGED THE STORY. CALLER STATED HER HUSBAND HAD BEEN DOSING HIMSELF BASED ON THE PRIME METER READINGS, PASSED OUT AND WAS NON-RESPONSIVE SO THEY CALLED THE AMBULANCE. WHEN EMTS ARRIVED THEY CHECK HIS BLOOD SUGAR AND IT WAS 35 ON THEIR METER AND THE PRIME READ 134. EMTS GAVE HIM SOMETHING TO REVIVE HIM. CALLER BELIEVES HER HUSBAND WAS BASING HIS MEDICATION ON INACCURATE READINGS, WHICH CAUSED THE INCIDENT. WE HAVE ATTEMPTED TO CONTACT THE CUSTOMER MULTIPLE TIMES TO GET MORE INFORMATION ON THE INCIDENT AND REQUEST PRODUCT BACK FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243313 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R