BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3935755 · Received July 15, 2014

    Report

    Report Number
    1832816-2014-00059
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 STATED THE PRIME METER HAS BEEN READING VERY HIGH. SHE TOOK BLOOD TEST IN AFTERNOON ON (B)(6) 2014 AND GOT 270. SHE WAS FEELING DIZZY AND LIGHT HEADED. SHE GOT ALARMED AND WENT TO ER AND WHEN THE HOSPITAL CHECKED IT SHE WAS 69 SO THEY GAVE HER 4 GLASSES OF ORANGE JUICE TO BRING SUGAR UP AND WENT HOME WHEN SUGAR WAS UP IN "NORMAL" RANGE. SHE WORKS NIGHTS SO SHE WOULD SLEEP DURING THE DAY. SHE SAID THE 270 WAS FASTING BECAUSE SHE HAD JUST GOTTEN UP. SHE IS A NEWLY DIAGNOSED DIABETIC SO SHE DOES NOT HAVE HER TYPICAL RANGE FIGURED OUT YET. SHE TOOK CLASS FOR NEW DIABETICS AND THEY SHOWED HER TECHNIQUE AND STORAGE AND I BELIEVE SHE IS DOING TESTING PROPERLY. SHE TRIED TEST ON HER FRIEND WHO ALSO HAS PRIME METER AND METER WAS READING HIGHER FOR HER ALSO. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412063 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 05134C

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R