BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1960609 · Received January 13, 2011

    Report

    Report Number
    2954323-2011-00615
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 12, 2010
    Report Date
    July 14, 2011
    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

    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

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(4)-2011. AS PER THE ARRANGEMENTS DISCUSSED WITH THE OFFICE OF SURVEILLANCE AND BIOMETRICS AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4)-2011 LETTER ADDRESSED TO (B)(4).

    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.

    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. SPECIFICALLY, THE CUSTOMER STATED "AFTER TAKING SUCH LOW READINGS" SHE HAS BEEN TREATING HERSELF "DIFFERENTLY CAUSING HER TO HAVE SWEATS AND FAINTING." THE CUSTOMER STATED ON (B)(6) 2010 AT APPROXIMATELY 0301AM WHILE AT HOME SHE RECEIVED A READING OF 78MG/DL USING THE AFFECTED LOT EXPERIENCED "SWEATING PROFUSELY" AND REPORTED A LOSS OF CONSCIOUSNESS. ALTHOUGH THE CUSTOMER INITIALLY STATED SHE HAD "TREATED THEMSELVES DIFFERENTLY" NO SPECIFIC TREATMENT MEDICATION/ROUTE OF ADMINISTRATION WAS REPORTED. CUSTOMER WAS SEEN AT A HEALTH CARE FACILITY HOWEVER, NO DIAGNOSIS WAS REPORTED. CUSTOMER FURTHER STATED SHE WAS TREATED WITH "BLOOD TESTS, URINALYSIS AND A CT OF THE KIDNEYS" AND WAS GIVEN "GLYBURIDE AND METFORMIN" TO HELP COUNTERACT THE MEDICAL EVENT. NO EMERGENT THIRD PARTY MEDICAL INTERVENTION WAS REPORTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A527

    Patients

    Seq Age Sex Outcome Treatment
    1 Other