BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3021644 · Received March 26, 2013

    Report

    Report Number
    1832816-2013-00024
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. THE METER INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS EVALUATED WITH RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME WAS GIVING VARIABLE READINGS. CUSTOMER STATED SHE TOOK HER BLOOD SUGAR IN THE MORNING AND RECEIVED A READING OF 40MG. SHE DIDN'T EAT THAT MORNING DUE TO BEING BUSY. SHE NORMALLY TAKES HER READING AROUND 8AM. SHE STATED SHE FELT THAT WASN'T RIGHT BECAUSE SHE DIDN'T FEEL LIKE ANYTHING WAS WRONG WITH HER. SHE THEN TESTED 8 MINUTES LATER AND RECEIVED A BLOOD SUGAR READING OF 333MG. SHE STATED, THERE IS NO WAY THAT WAS ACCURATE. SHE STATED SHE DIDN'T TAKE ANOTHER READING UNTIL DINNER TIME THEN SHE RECEIVED 157MG. SHE STATED, SHE CALLED THE DOCTOR'S OFFICE TO CONSULT ABOUT HER READINGS THEN THE DOCTOR INFORMED HER TO GO TO (B)(6) THEN (B)(6) INSTRUCTED HER TO CONTACT ARKRAY. CONTROLS NOT USED. CUSTOMER REQUESTED REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124055 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 01313B

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR