BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3213948 · Received July 9, 2013

    Report

    Report Number
    1832816-2013-00060
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 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

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. 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 READING HIGH. THIS MORNING CUSTOMER TOOK A READING AND GOT 579 AND WENT BACK TO BED. ABOUT 8:45 HE TOOK ANOTHER READING AND IT WAS 511 SO HE DECIDED TO GO TO THE CLINIC BECAUSE HE WAS CONCERNED BECAUSE IN THE PAST 6 WEEKS HE HAS BEEN GETTING HIGH READING. AT 12:45PM HE TOOK ANOTHER READING AND GOT 591 AND DOCTOR GOT CONCERNED AND THEY GAVE HIM 10 UNIT OF FAST ACTING INSULIN. HE WAS ASKED TO WAIT AND SEE IF THE READING WOULD GO DOWN AND AT 1:35 HE WAS TESTED WITH HIS METER AND GOT 580 AND HE WAS GIVEN ANOTHER 10 UNITS SO HE WAITED AND AT 2:30 HE WAS TESTED AGAIN AND GOT A READING OF 517, SO HE WAS GIVEN 10 UNITS MORE. AT 4:39 HE DID A TEST AND GOT 439 DOCTOR SAID THAT GLUCOSE SHOULD'VE GONE DOWN LOWER THAN THE 439 SO THEY DID A TEST WITH DOCTOR'S METER AND THE OTHER METER READ 329. CUSTOMER CLAIMS HE COULD HAVE DIED IF HE WOULD HAVE KEPT DOSING WITH INSULIN BASED ON READING ON RELION PRIME METER. HE WAS TOLD TO GO BACK ON FRIDAY AND HE WENT HOME AND CALLED US. HE WASHES HIS HANDS AND USES NEW LANCET EVERY TIME HE DOES A TEST AND HE IS STORING STRIPS IN THE KITCHEN DID LET HIM KNOW THAT IS NOT A RECOMMENDED PLACE, CUSTOMER WOULD LIKE TO KNOW THE OUTCOME OF EVERYTHING HE IS VERY DISAPPOINTED WITH WHAT HAPPEN AND A REPLACEMENT OR REFUND WOULD NOT SOLVE WHAT HAPPEN TO HIM. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312493 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 04173A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening