BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2001928 · Received February 27, 2011

    Report

    Report Number
    2954323-2011-01754
    Event Type
    Injury
    Date Received
    February 27, 2011
    Date of Event
    December 24, 2010
    Report Date
    April 22, 2011
    Product Code
    NBW
    Removal / Correction Number
    ADC 1197-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT TESTING ON RETURNED STRIP LOT (45001A521) AND RETAINED METER ((B)(4)) DID NOT CONFIRM. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE RESULTS ARE CONSISTENT WITH THE RETAIN TESTING CONDUCTED, WHICH FOUND THAT NOT ALL STRIPS IN AFFECTED VIALS ARE IMPACTED. THIS IS A FINAL REPORT.

    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 30 DEGREES 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. 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 GETTING A LOWER THAN FEELS READING OF 67 MG/DL, FEELING JITTERY AND SLUGGISH, LOSING CONSCIOUSNESS AND REPORTEDLY "TOOK NOTHING SPECIAL" TO COUNTERACT THE EVENT. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other