BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1961838 · Received January 14, 2011

    Report

    Report Number
    2954323-2011-00683
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 14, 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'S PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED EITHER LONGER BLOOD FILL TIME OR READINGS ISSUES. SPECIFICALLY, THE CUSTOMER REPORTED RECEIVING READINGS OF 212MG/DL,194MG/DL AND 186MG/DL ON (B)(6) 2010 HOWEVER, THE CUSTOMER COULD NOT RECALL THE EXACT TIMES THE READINGS WERE OBTAINED. CUSTOMER STATED THEY EXPERIENCED SYMPTOMS OF "FATIGUE, THIRST AND A LOSS OF APPETITE" AND FURTHER REPORTED THEY DECREASED THEIR INSULIN DOSAGE BASED ON THE READINGS. NO THIRD PARTY MEDICAL INTERVENTION WAS REPORTED AND CUSTOMER DENIED SELF-TREATMENT FOR THEIR SYMPTOMS. THERE WAS NO REPORT OF SERIOUS INJURY, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 45841

    Patients

    Seq Age Sex Outcome Treatment
    1