BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2543796 · Received April 20, 2012

    Report

    Report Number
    1832816-2012-00034
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 4, 2012
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K082417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MICRO METER WAS GIVING VARIABLE READINGS. CALLER STATED THAT SHE RECEIVED A READING OF 25MG/DL WITH NO SYMPTOMS (HER PHARMACIST STATED THAT THE SINUS MEDICATION SHE WAS TAKING MAY HAVE BLOCKED HER SYMPTOMS). SHE STATED SHE ATE A HIGH CARB MEAL, AND DRANK ORANGE JUICE 5-10 MINUTES AFTER EATING. SHE TESTED AND HER RESULTS WERE HI FOR TWO TESTS, SHE TESTED A 3RD TIME IN 10 MINS AND THE RESULTS WERE 38MG/DL. I THEN ASKED WHAT TYPE OF DIABETES SHE HAS SHE STATED THAT SHE IS TYPE 2 INSULIN DEPENDENT, SO I ASKED IF SHE DOSED HERSELF WITH INSULIN AND SHE SAID THAT SHE HAD. SHE THEN STATED THAT SHE WAS FEELING VERY ILL THE NEXT COUPLE OF DAYS SWEATING, VOMITING AND THAT SHE THEN WENT TO THE EMERGENCY ROOM AND THAT SHE WAS "DKA". I HAD CALLER GO THROUGH THE METER MEMORY WITH ME AND SHE READ OFF TO ME ABOUT 46 READINGS THAT WERE FROM (B)(6) 2012 AND NONE OF THE READINGS MATCHED THE INFORMATION THAT SHE WAS PROVIDING ME. THERE WAS ONLY 3 OCCURRENCES WHERE THERE WERE MULTIPLE READINGS WITHIN 10 MINUTES, AND ONLY ONE INSTANCE WHERE THE RESULTS WERE OUTSIDE OF 20% THE READINGS WERE FROM (B)(6): 12:39PM HI, 12:38PM HI, 12:37 50 MG/DL. CALLER IS NOT CHANGING THE LANCET WITH EACH TEST, SHE IS USING (B)(6) HAND SANITIZER TO WASH HER HANDS. SHE IS STORING THE PRODUCT CORRECTLY. I HAVE EDUCATED ON BEST PRACTICES - USING SOAP AND WATER OR ALCOHOL PADS, BUT NOT TO USE HAND SANITIZER. ALSO I HAVE SUGGESTED THAT SHE TAKE HER METER TO A DIABETIC EDUCATOR AND EXPLAINED HOW THEY WOULD BE THE BEST PROFESSIONAL TO SPEAK TO IN ORDER TO GET THE BEST EDUCATION, AND INFORMATION IN REGARDS TO DIABETES. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION MICRO BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712001 M115A07

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L