BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 2012469 · Received March 9, 2011

    Report

    Report Number
    2954323-2011-02146
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    May 20, 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 (45734) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    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 (B)(4). ALL AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING (B)(4) 2010. NOTE: ACCORDING TO THE REPORT THE EVENT OCCURRED IN (B)(6) 2010, BUT THE EXACT DATE IS UNKNOWN. THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTTS PRECISION FAMILY TEST STRIPS, THE CUSTOMER'S CAREGIVER REPORTED THE CUSTOMER RECEIVED UNSPECIFIED READINGS WHICH WERE LOWER THAN HE FELT. ACCORDING TO THE CUSTOMER'S CAREGIVER REPORT, THE CUSTOMER EXPERIENCED A MEDICAL EVENT IN (B)(6) 2010 OVER SEVERAL DAYS (NO SPECIFIC DATE IS AVAILABLE) WHEN HE FELT SYMPTOMS OF BLURRED VISION AND DIZZY SPELLS, BUT HE DID NOT HAVE LOSS OF CONSCIOUSNESS OR SEIZURE. THE CUSTOMER'S CAREGIVER ALSO REPORTED THE CUSTOMER WAS SEEN BY A DOCTOR AND ALTHOUGH NO MEDICAL DIAGNOSIS IS AVAILABLE, HIS DOCTOR ADDED A NEW DIABETES MEDICATION TO THE CUSTOMER'S DRUG REGIMEN (ACTOS). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 45734

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention