BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3103099 · Received May 9, 2013

    Report

    Report Number
    1832816-2013-00037
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 23, 2013
    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

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME METER WAS GIVING HIGH READINGS. CUSTOMER STATED SHE TOOK HER BLOOD SUGAR BEFORE EATING BREAKFAST. AT THE TIME SHE RECEIVED 142 ON THE PRIME METER. NEXT SHE TOOK INSULIN ACCORDING TO THAT READING. THEN SHE ATE BREAKFAST. AFTER SHE ATE BREAKFAST SHE WENT FOR A WALK WITH HER HUSBAND AND THEIR DOG. SHE STATED 25 MINUTES INTO HER WALK SHE TESTED HER BLOOD AGAIN AND GOT A READING OF 89. SHE CONTINUED TO WALK FOR ABOUT 5 MINUTES THEN STARTED TO FEEL SICK. SHE STATED SHE FELT DIZZY, SORT OF WANTING TO CRY AND FELT LIKE SHE WANTED TO PASS OUT. SHE SAT DOWN ON THE CURB. HER HUSBAND TESTED HER BLOOD SUGAR AT THAT TIME AND GOT A READING OF 87. NEXT HE GAVE HER SOME SYRUP AND WATER AFTER THAT SHE WAS ABLE TO WALK HOME. SHE DECIDED TO TEST HER BLOOD AGAIN ON AN ACCU-CHEK METER RECEIVING A READING OF 23. SHE STATED SHE USED CONTROLS, BUT NO RECORD OF US SENDING HER SOLUTION SO MOST LIKELY SHE WAS NOT USING THE CORRECT SOLUTION. CUSTOMER REQUESTING REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203011 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 03183A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening