BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION XTRA

    MDR report key: 2001921 · Received February 27, 2011

    Report

    Report Number
    2954323-2011-01753
    Event Type
    Death
    Date Received
    February 27, 2011
    Date of Event
    December 8, 2010
    Report Date
    June 6, 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 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE COMPLAINT AND HAVE BEEN UNSUCCESSFUL.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(6)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CUSTOMER'S WIFE INFORMED ABBOTT DIABETES CARE THAT ON OR AROUND (B)(6) 2010, HER HUSBAND RECEIVED LOW READINGS AND WAS REPORTEDLY SLEEPING A LOT AND EXPERIENCING FREQUENT URINATION COUPLED WITH SHORT-TERM MEMORY LOSS. THE CUSTOMER WAS HOSPITALIZED DUE TO ELEVATED BLOOD GLUCOSE LEVELS AND THE PHYSICIAN CHANGED HIS MEDICATION TO REGULATE HIS BLOOD GLUCOSE LEVEL. IT IS UNKNOWN WHEN THE HOSPITALIZATION OCCURRED. THE CUSTOMER'S WIFE ALSO REPORTED THAT ON (B)(6) 2010 HER HUSBAND WAS INVOLVED IN A CAR ACCIDENT AND WAS PRONOUNCED DEAD AT THE SCENE. ALTHOUGH THE CUSTOMER'S MEDICAL CONDITION JUST PRIOR TO THE CAR ACCIDENT REMAINS UNKNOWN, PARAMEDICS CALLED TO THE ACCIDENT SCENE REPORTEDLY STATED THE HUSBAND'S DEATH WAS THE RESULT OF BLUNT FORCE TRAUMA. THE CUSTOMER WAS REPORTEDLY USING TEST STRIPS FROM AN AFFECTED LOT RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT'S PRECISION FAMILY TEST STRIPS. IT SHOULD ALSO BE NOTED THAT ALTHOUGH THE DEVICE'S MEMORY LOG DID HAVE A LOW READING OF 74 MG/DL STORED, THAT READING WAS THE LAST READING REGISTERED AND IT WAS FROM (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A670

    Patients

    Seq Age Sex Outcome Treatment
    1 Death