BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1971319 · Received January 26, 2011

    Report

    Report Number
    2954323-2011-01158
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 16, 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

    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

    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

    A CUSTOMER CALLED CUSTOMER SERVICES ON (B)(6) 2010 IN REFERENCE TO THE ON-GOING FIELD ACTION FOR ABBOTT'S PRECISION FAMILY TEST STRIPS. CUSTOMER INDICATED HE HAD PRECISION XTRA TEST STRIPS AND DURING THE COURSE OF THE CONVERSATION RESPONDED "YES" WHEN ASKED IF HE HAD SUSTAINED AN INJURY ASSOCIATED WITH THE USE OF THE TEST STRIPS. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE ORIGINAL CALL. TWO, UNSUCCESSFUL, ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. IT IS UNKNOWN WHAT, IF ANY, TREATMENT WAS RENDERED, EITHER VIA SELF OR THIRD-PARTY EMERGENT INTERVENTION. THERE WAS NO REPORT OF DEATH OR MISTREATMENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 46105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other