BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3200297 · Received July 1, 2013

    Report

    Report Number
    2954323-2013-00361
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. NO FURTHER INVESTIGATION WILL BE UNDERTAKEN. THE CUSTOMER'S FAILURE TO CALIBRATE THEIR DEVICE WAS DUE TO THEIR NOT HAVING A CALIBRATION BAR TO USE. CUSTOMER WAS USING TWO DIFFERENT ADC BLOOD GLUCOSE METERS AT THE TIME OF THE EVENT. A SEPARATE MDR WILL BE FILED FOR THE SECOND DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED CUSTOMER SERVICE ON (B)(6) 2013, TO REPORT HE WAS UNABLE TO CALIBRATE HIS ADC BLOOD GLUCOSE METER. AT THE TIME OF THE ORIGINAL CALL, CUSTOMER DENIED EXPERIENCING ANY SYMPTOMS OR AN INJURY DUE TO THIS ISSUE. CUSTOMER WAS PROMISED A NEW METER, VIA A NEXT-DAY DELIVERY, TO BE RECEIVED BY 5:00 PM, ON (B)(6) 2013. CUSTOMER'S DAUGHTER REPORTED THAT AT "AROUND 6:30 AM", (ON (B)(6) 2013), CUSTOMER WAS FOUND TO BE UNRESPONSIVE, AFTER HAVING EXPERIENCED A LOSS OF CONSCIOUSNESS AND A SEIZURE. CALLER BELIEVED THE EVENT HAPPENED DUE TO THE CALIBRATION ISSUE, BUT ALSO BECAUSE CUSTOMER HAD NOT YET RECEIVED HIS NEW ADC BLOOD GLUCOSE METER. PARAMEDICS WERE CALLED AND UPON ARRIVAL, CHECKED HIS GLUCOSE USING AN UNKNOWN BRAND OF METER, RECEIVED A READING OF 25 MG/DL AT 7:15 AM, INITIATED AN INTRAVENOUS INFUSION OF UNKNOWN TYPE, WITH INTRAVENOUS GLUCOSE AND TRANSPORTED HIM TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH ADDITIONAL INTRAVENOUS GLUCOSE. A READING OF 87 MG/DL WAS RECEIVED AT THE HOSPITAL AT 8:30 AM. CALLER ALSO NOTED SHE WAS ADVISED BY HER FATHER'S PHYSICIAN THAT HE MAY HAVE SUFFERED A "STROKE" PRIOR TO BECOMING UNRESPONSIVE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298695 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 4500161274

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R