BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 4090157 · Received September 15, 2014

    Report

    Report Number
    1832816-2014-00072
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION METER WAS READING HIGH. CALLER STATED SHE WAS GOING INTO A COMA BECAUSE HER BLOOD SUGAR WAS SO LOW. HER SON TOOK HER SUGAR BECAUSE HE WAS NOT ABLE TO WAKE HER UP AND IT READ 500, SO HE CALLED THE EMTS WHO ARRIVED 10 MINUTES LATER. THEY CHECKED HER SUGAR WITH THEIR METER AND IT WAS 28. THEY GAVE HER AN INTRAVENOUS GLUCOSE SHOT, BUT HER SUGAR DIDN'T GO UP, SO SHE HAD A PEANUT BUTTER SANDWICH AND MILK. THE EMTS STAYED UNTIL HER SUGAR WENT BACK UP WHICH WAS APPROXIMATELY AN HOUR. TECHNIQUE AND STORAGE ARE GOOD. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569040 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 06034C

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R