BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 2851528 · Received November 29, 2012

    Report

    Report Number
    1832816-2012-00110
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    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 CONCERNED WITH METER GIVING HIGH READINGS. STATING SHE IS HAVING PROBLEMS WITH INSULIN INTAKE BASED ON METER READINGS. STATED METER READING TOO HIGH AND SHE'S TAKING TOO MUCH INSULIN, WHICH IS RESULTING IN HER SUGAR DROPPING TOO MUCH IN THE MIDDLE OF THE NIGHT. SHE FEELS THIS IS VERY DANGEROUS. CALLER TRANSFERRED. RECEIVED TRANSFER CALL: CALLER WANTED TO KNOW HOW ACCURATE HER METER IS BECAUSE SHE HAS BEEN GETTING HIGH READINGS AND IS DOSING HERSELF BASED ON THE READINGS. CALLER IS ON A SLIDING SCALE AND BASIS TREATMENT ON READINGS. SHE DIDN'T SPECIFY HOW MANY UNITS SHE TAKES SHE SAID IT'S BASED ON THE READING SHE GETS. THIS MORNING SHE HAD AN APPOINTMENT WITH HER DOCTOR AND TOOK HER METER WITH. WHILE WAITING IN THE LOBBY, SHE TOOK HER READING, GOT APPROXIMATELY 300, THEN TOOK HER MEDICATION AS SHE NORMALLY WOULD AFTER DOING HER READINGS. THREE MINUTES LATER, SHE TOOK HER READING WITH THE DOCTOR'S METER AND IT WAS 199. BASE ON THIS READING, SHE CALCULATED THAT SHE HAD TAKEN 4 UNITS MORE THEN SHE SHOULD HAVE. DOCTOR DID NOT SAY OR ADVISE TO TAKE OTHER MEDICATION. SHE HASN'T BEEN ABLE TO DO A CONTROL SOLUTION TEST BECAUSE SHE DOESN'T HAVE SOLUTION. SHE STATED SHE HAD NOT EATEN PRIOR TO THE TEST. SHE IS USING THE FIRST DROP OF BLOOD. EDUCATED HER THAT WE RECOMMEND USING THE SECOND DROP OF BLOOD AND SHE SAID SHE'S BEEN DOING IT FOR YEARS AND HAS NEVER HEARD ABOUT THE SECOND DROP. DID TELL HER I WOULD REPLACE HER PRODUCT AND SEND SOLUTION SO SHE CAN TEST HER METER. ATTEMPTED TO GATHER MORE INFORMATION, BUT CALLER WAS NOT COOPERATIVE STATING SHE DID NOT HAVE TIME.

    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 08282A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening