BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 5224437 · Received November 15, 2015

    Report

    Report Number
    1832816-2015-00048
    Event Type
    Injury
    Date Received
    November 15, 2015
    Date of Event
    October 18, 2015
    Report Date
    November 13, 2015
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE SAME LOT OF TEST STRIPS BELIEVED TO BE INVOLVED IN THE INCIDENT WERE TESTED RECENTLY AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME METER WAS GIVING LOW READINGS. JUST BOUGHT ON SATURDAY, (B)(6) 2015. CALLER STATED ALL READINGS HAVE BEEN 100 PTS LOWER THAN WHAT SHE ACTUALLY WAS. METER READ 111, BUT THINKS HER SUGAR WAS ACTUALLY AROUND 300 AT THAT POINT. ON SUNDAY, (B)(6) 2015, METER READ 260, 245. SHE WAS FEELING HIGHER THAN WHAT THE METER WAS READING. PATIENT USES AN INSULIN PUMP AND SHE WAS NOT GIVING HERSELF PROPER CORRECTION WITH THE AMOUNT OF INSULIN BECAUSE OF THE LOW METER READINGS. SHE WAS FEELING DIZZY, JITTERY AND WAS BECOMING DELUSIONAL BECAUSE HER SUGAR WAS RUNNING HIGH. CALLER WORKS FOR THE FIRE DEPARTMENT AND STARTED HER WITH A SALINE IV BEFORE BRINGING HER TO THE HOSPITAL. THE METER READ 234 BEFORE GOING TO HOSPITAL AT 3:17 PM AND 4 MINUTES LATER THE HOSPITAL READING WAS 512. SHE WAS UNCONSCIOUS BY THE TIME THEY GOT TO THE HOSPITAL. THEY SWITCHED SALINE BAGS, GAVE NAUSEA MEDS AND REGULATED HER BLOOD SUGAR. SHE WAS STILL IN HOSPITAL BEING MONITORED. PROPER TECHNIQUE WAS USED. CONTROLS NOT USED. REQUESTING REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753896 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 08125B

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L