BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2252066 · Received September 16, 2011

    Report

    Report Number
    2954323-2011-04506
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 9, 2011
    Report Date
    November 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN TESTING WAS NOT PERFORMED DUE TO STRIP LOT NUMBER 45001A419 BEING EXPIRED. A DHR REVIEW OF THE STRIP HAS BEEN COMPLETED. THE DEVICE HISTORY REVIEW FOR TEST STRIP LOT 45001A419 INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. ADDITIONALLY: THE LOT NUMBER OF THE OTHER TEST STRIP IS UNKNOWN. SEVERAL, UNSUCCESSFUL, ATTEMPTS TO CONTACT THE CUSTOMER TO GATHER FURTHER INFORMATION HAVE BEEN MADE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING OF 5.9 MMOL/L (106 MG/DL) ON HER PRECISION XTRA BLOOD GLUCOSE METER WHICH WAS LOWER WHEN COMPARED TO A READING OF 7.2 MMOL/L (130 MG/DL) RECEIVED USING A DIFFERENT TEST STRIP LOT, WITHIN 10 MINUTES OF EACH OTHER. CUSTOMER FURTHER ACKNOWLEDGED SUSTAINING AN UNSPECIFIED INJURY AS A RESULT, BUT DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other