BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3021696 · Received March 26, 2013

    Report

    Report Number
    1832816-2013-00025
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 9, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME WAS GIVING VARIABLE READINGS. THE CUSTOMER STATED HE WOKE UP IN THE MORNING TO TAKE HIS BLOOD SUGAR. HE RECEIVED A READING OF 343MG AND STARTED TO WONDER WHY IT TESTED SO HIGH. NEXT HE TOOK HUMALOG TO GET HIS BLOOD SUGAR TO DECREASE BUT HE TOOK MORE THAN WHAT HIS DAILY DOSE NORMALLY IS. HE THEN WAITED TO TEST 2 HOURS LATER TO CHECK IF HIS LEVELS HAD DROPPED. HE STATED HE RECEIVED A READING OF 159MG AND FELT THAT WAS OK BECAUSE HIS NORMAL READINGS RANGE FROM ABOUT 98 TO 100. HE STATED HE TESTED AGAIN ANOTHER 2 HOURS LATER BUT THIS TIME HE RECEIVED A READING OF 57. HE STATED HE WAS FEELING DIZZY AND SHAKY. HIS WIFE GAVE HIM SOME ORANGE JUICE AND SUGAR TO INCREASE HIS BLOOD SUGAR. HE DECIDED HE DOES NOT TRUST THE PRIME METER AND NO LONGER WANTED TO USE IT. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123364 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 01313B

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening