BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION CONFIRM BLOOD GLUCOSE TEST SYSTEM

    MDR report key: 7213493 · Received January 23, 2018

    Report

    Report Number
    1832816-2018-00001
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    December 24, 2017
    Report Date
    December 28, 2017
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    UDI-DI
    00605388860163
    PMA / PMN Number
    K124021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Description of Event or Problem · 1

    CALLER STATED HE IS RECEIVING VERY HIGH READINGS. CUSTOMER STATED THE FIRST COUPLE WEEKS THE RESULTS WERE NORMAL. THE PAST WEEK AND A HALF HE HAS BEEN RECEIVING HIGH READINGS IN THE 240-320 RANGE. CALLER STATED HE MIS-DOSED DUE TO A METER RESULT OF 392 ON (B)(6) 2017 AT 1:32 PM. BECAUSE OF THE READING, HE TOOK HIS RAPID ACTING INSULIN (HUMALOG) AND HIS LONG-LASTING INSULIN (LANTUS). HE STARTED HAVING SYMPTOMS RIGHT AWAY. THE AMBULANCE/PARAMEDICS WERE CALLED AND THEY ARRIVED AROUND 2:00 PM, WHERE THEY ADMINISTERED A GLUCOSE PUSH AND TRANSPORTED HIM TO THE ER WHERE THEY ADMINISTERED A GLUCOSE DRIP. ONCE TREATMENT WAS COMPLETED, CALL WAS RELEASED. CALLER BELIEVES THE READING IN QUESTION WAS INACCURATE. CUSTOMER ONLY HAS ONE TEST STRIP LEFT FROM THIS LOT OF STRIPS. I ASKED HIM TO SEND IT BACK TO US. CALLER IS INSULIN DEPENDENT. CALLER IS ON OXYGEN THERAPY. CALLER IS ON NUMEROUS MEDICATIONS DUE TO MULTIPLE HEALTH ISSUES. CALLER'S TESTING TECHNIQUE IS CORRECT. CONTROLS WERE USED AND RESULTS WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56682 RELION CONFIRM BLOOD GLUCOSE TEST SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712002 E175D25 00605388860163

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R