BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 2832175 · Received November 14, 2012

    Report

    Report Number
    1832816-2012-00105
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 RELION PRIME METER WAS GIVING HIGH READINGS. RECEIVED TRANSFER CALL FROM CE STATING THE CUSTOMER WAS GETTING READINGS 200 POINTS DIFFERENT FROM HIS 'GOOD METER' AND STATED HE CRASHED BECAUSE HE TOOK TOO MUCH INSULIN BASED ON THE PRIME METER READING. THE CUSTOMER BOUGHT HIS METER LAST WEEK AND THEN SATURDAY HE CRASHED. HE STATED HE WAS COMATOSE AND WAS PASSED OUT FOR A FEW HOURS AND HIS FRIENDS COULD NOT WAKE HIM. ON (B)(6) AT 3:55PM, HE DOSED HIMSELF WITH 8 UNITS OF INSULIN BASED ON A 268 READING WITH THE PRIME METER. HE LEFT THE HOUSE AND ATE A (B)(4) AND DRANK A SODA. HE RETURNED HOME AT 6:09PM AND FELT HIS HEART POUNDING AND LEGS GOT WEAK. STATED HE WAS SO WEAK HE COULD NOT LIFT ANYTHING. HE ATE CANDY AND DRANK JUICE AND HIS SUGAR LEVELS DID NOT ELEVATE. HE TOOK A READING WITH HIS 'GOOD METER' AND IT WAS 47. THEN HE PASSED OUT FOR 3 ½ HOURS AND WAS AWOKEN BY A FRIEND TRYING TO REACH HIM BY PHONE. HE TOOK ANOTHER READING AND HE WAS 338, WHICH HE BELIEVED BECAUSE HE WAS DUE TO TAKE HIS INSULIN. READINGS FROM MEMORY UP TO INCIDENT READING. (B)(6) 1:22A 291, (B)(6) 4:12A 417, (B)(6) 11:19A 293, (B)(6) 3:55P 268. CALLER STATED THE METERS AT (B)(4) ALSO LOOKED LIKE THEY HAD DAMAGE. HE STATED HE THINKS THAT HAS SOMETHING TO DO WITH THE METER WORKING IMPROPERLY. HE DOESN'T BELIEVE WE WOULD MAKE A METER THAT WILL READ SO MANY POINTS OFF. CUSTOMER NO LONGER HAS STRIPS SO WAS UNABLE TO ATTAIN THE LOT NUMBER. HE IS STORING PRODUCT PROPERLY. HE DOES NOT WASH HIS HANDS EVERY TIME BUT HE DID ON THE DAY OF THE INCIDENT. HE ALSO DOES NOT ALWAYS CHANGE LANCETS. I HAVE EDUCATED ON THE PROPER TESTING TECHNIQUE. REPLACING METER AND STRIPS AND SENDING CONTROL SOLUTION AS HE HAS NONE ON HAND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening