BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 1951736 · Received January 6, 2011

    Report

    Report Number
    2954323-2011-00100
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 2, 2010
    Report Date
    January 6, 2011
    Product Code
    NBW
    Removal / Correction Number
    ADC FA1197-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLES OF PRECISION TEST STRIP LOTS MANUFACTURED WITH HOT-MELT GLUE BATCHES EXHIBITED LOWER THAN EXPECTED READINGS ON CONTINUOUS STORAGE AFTER NINE MONTHS AT 30 DEGREE CELSIUS DURING ROUTINE STABILITY PERFORMANCE TESTING. THIS STABILITY ISSUE COULD LEAD TO THE GENERATION OF INCORRECTLY DEPRESSED BLOOD GLUCOSE RESULTS AND THESE ERRONEOUS RESULTS MAY BE IN THE C, D OR E ZONES OF PARKES ERROR GRID, AND AS SUCH, HAVE THE POTENTIAL TO BE CLINICALLY SIGNIFICANT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. CUSTOMERS WILL BE NOTIFIED THROUGH A REMEDIAL ACTION ADC FA1197-2010. NOTE: DURING THE COURSE OF THE TROUBLESHOOTING SURVEY, THE CUSTOMER ALSO REPORTED THERE WAS A FOREIGN MATERIAL (AND/OR BLOOD/CONTROL SOLUTION) IN THE METER PORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2010, HE RECEIVED ON HIS PRECISION XTRA BLOOD GLUCOSE METER A READING OF 279 MG/DL AT 7:40 PM AND THEN TOOK HIS INSULIN. THE CUSTOMER REPORTEDLY STARTED SWEATING AND FEELING FUNNY, AND THEN DRANK THREE CUPS OF (B)(6) WITH SUGAR TO BRING HIS BLOOD GLUCOSE LEVEL UP. WHEN THE CUSTOMER TESTED HIS BLOOD GLUCOSE AGAIN ON THE SAME DAY AT 10:23 PM, HE REPORTED HE RECEIVED A READING OF 49 MG/DL, BUT THERE WAS NO REPORT OF THE CUSTOMER TAKING ANY ADDITIONAL MEDICATION TO COUNTERACT SUCH READING. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A744

    Patients

    Seq Age Sex Outcome Treatment
    1