BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 2024322 · Received March 18, 2011

    Report

    Report Number
    2954323-2011-02378
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 18, 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 30C 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. THE PRIMARY CAUSE HAS BEEN IDENTIFIED TO BE BATCH TO BATCH GLUE VARIABILITY. THE FDA HAS BEEN INFORMED OF THE FIELD ACTION PER 21CFR806 (FIELD ACTION REFERENCE NUMBER 2954323-12/22/10-001-R). ALL AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING DECEMBER 22, 2010.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT'S PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED EITHER LONGER BLOOD FILL TIME OR READINGS ISSUES. A CUSTOMER REPORTED AS A RESULT OF GETTING LOWER THAN FEELS READINGS, HE STOPPED TAKING HIS MEDICATION, WHICH RESULTED IN HYPERGLYCEMIA. HE REPORTEDLY "TALKED REALLY FAST AND SAID THINGS THAT HE WOULD NOT HAVE SAID IF HE WASN'T HYPER. GOT INTO FIGHT WITH HIS MOTHER. HAD CRAMPS IN FEET AND LEGS." THE CUSTOMER FURTHER REPORTED HE WENT TO SEE A DOCTOR WHO DIAGNOSED HIM WITH HYPERGLYCEMIA AND "REFERRED HIM TO AN EYE SPECIALIST BECAUSE HIS EYES WERE AFFECTED BY HIGH BLOOD SUGAR AND HE NEARLY HAD SURGERY BUT HE REFUSED AND HE IS CONSTANTLY BEING MONITORED." THE CUSTOMER REFUSED TO COMPLETE THE MEDICAL SURVEY, HENCE, NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON EXISTING INFORMATION, THERE IS NO INDICATION ADC DEVICE CONTRIBUTED TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A979

    Patients

    Seq Age Sex Outcome Treatment
    1