BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 2020343 · Received March 16, 2011

    Report

    Report Number
    2954323-2011-02231
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 16, 2011
    Product Code
    NBW
    Removal / Correction Number
    ADC FA1197-2010
    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.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED LONGER BLOOD FILL TIME AND READINGS ISSUES. A CUSTOMER REPORTEDLY WOKE UP FEELING VERY TIRED AND WEAK, TOOK READING AND OBTAINED LOWER THAN FEELS READINGS. THE CUSTOMER FURTHER REPORTED EXPERIENCING CHEST PAIN, SELF-TREATING WITH NITROGLYCERIN AND GOING TO THE HOSPITAL FOR A REGULAR CHECK-UP WHERE THEY WERE DIAGNOSED WITH HYPERTENSION. NEITHER DIABETES-RELATED DIAGNOSIS NOR TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 45608

    Patients

    Seq Age Sex Outcome Treatment
    1