BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 2972833 · Received February 21, 2013

    Report

    Report Number
    1832816-2013-00015
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 3, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PRIME METER WAS GIVING VARIABLE READINGS. RECEIVED TRANSFER CALL FROM CE REP WHERE THE CALLER STATED SHE "ALMOST DIED" BECAUSE THE PRIME READ OVER 200, SHE TOOK INSULIN AND DROPPED TO 60. CONTACTED CUSTOMER TO GATHER DETAILS ON INCIDENT. CUSTOMER STATED THAT ON SATURDAY SHE HAD LUNCH AROUND 1 PM, TOOK HER GLUCOSE READING AND GOT 298 SO SHE TOOK HER INSULIN. A FEW HOURS LATER SHE STARTED FEELING SHAKY AND COULD NOT WALK BECAUSE HER LEGS WERE NOT RESPONDING. SHE THEN TOOK A TEST AT 4:25PM AND GOT A READING OF 68. SHE TESTED AGAIN AT 4:34PM AND HER READING WAS 87 SO SHE HAD SOME ORANGE JUICE TO RAISE HER GLUCOSE. LATER SHE TESTED HERSELF AGAIN AT 5:16PM AND GOT A READING OF 289. SHE WAS NOT SURE IF SHE SHOULD TAKE HER INSULIN SO MINUTES LATER SHE TESTED AT 5:39PM AND GOT A READING OF 48. SHE THOUGHT THAT WAS TOO LOW SO SHE IMMEDIATELY TESTED AGAIN AND GOT 289. SHE DID NOT TAKE ANY MORE MEDICATION. SHE DID TEST AN HOUR LATER AT 6:39 AND GOT A READING OF 320. SHE IS NOT CHANGING LANCET, NOT WASHING HANDS ALL THE TIME AND USES HAND SANITIZER. STORING STRIPS IN KITCHEN AND PURSE. EXPLAINED PROPER TECHNIQUE AND STORAGE. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76000 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 11132A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening