BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1973415 · Received January 30, 2011

    Report

    Report Number
    2954323-2011-01271
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Removal / Correction Number
    ADC FA1197-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. 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.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS ADDITIONAL INFORMATION. THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH CONTROLLED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTTS PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED EITHER LONGER BLOOD FILL TIME OR READINGS ISSUES. THE CUSTOMER ALSO STATED SHE FELL DOWN THE STAIRS BECAUSE OF THE PRODUCT AND ALSO MENTIONED THAT SHE JUST "CAME OUT OF A COMA IN THE HOSPITAL. " THE CUSTOMER REFUSED TO FURTHER TROUBLESHOOT AND COMPLETE THE MEDICAL SURVEY; HENCE, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 45001A982

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O