BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBASE NON-DERIVATIZED MSMS KIT

    MDR report key: 2850407 · Received November 26, 2012

    Report

    Report Number
    8043909-2012-00002
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 26, 2012
    Manufacturer
    WALLAC OY
    Product Code
    NQL
    PMA / PMN Number
    K083130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # 618763, MANUFACTURE DATE: 06/2012. THE TRUNCATED V-BOTTOMED MICROPLATE HAS EXHIBITED DEFECTS; PRESENTING AS HOLE(S) OR CRACK(S) IN THE BOTTOM OF SOME WELLS. DURING THE EXTRACTION INCUBATION STEP OF AFFECTED ASSAYS, THE EXTRACTION SOLUTION LEAKS FROM THE WELLS LEAVING THE WELL EMPTY ALMOST EMPTY OR WITH A USABLE VOLUME OF SOLUTION. THIS MAY RESULT IN THE FOLLOWING SCENARIOS OCCURRING. SCENARIO 1: WHEN LEAKAGE OCCURS, IN APPROXIMATELY 80% OF THE OCCURRENCES THE RESULT IS AN EMPTY OR NEAR EMPTY WELL AFTER THE INCUBATION. THE TEST CANNOT PHYSICALLY PROCEED DUE TO THE LACK OF SOLUTION. IN THIS SCENARIO THE SAMPLE MUST BE REPEATED. THE DELAY EXPERIENCED IS A DELAY IN THE REPORTING OF THE RESULTS. SCENARIO 2: AFTER FIRST INCUBATION THE WELL HAS SUFFICIENT SOLUTION REMAINING IN THE WELL TO PHYSICALLY PROCEED WITH TESTING, HOWEVER THE SOLUTION IS DECREASED IN VOLUME FROM THE EXPECTED AMOUNT ROUTINELY PRESENT AFTER INCUBATION. IN THIS SCENARIO THE SAMPLE CONCENTRATION MEASURED MAY BE FALSELY LOW OR HIGH AND IN THE WORST CASE RESULT IN FALSE NEGATIVE SCREENING RESULT TO BE REPORTED. THE REPORTING OF A FALSE NEGATIVE SCREENING INTERPRETATION RESULTS MAY DELAY THE DIAGNOSIS OF THE DISORDER. DEPENDING ON THE SEVERITY OF THE DISORDER THE FALSE NEGATIVE MAY RESULT IN SERIOUS DETERIORATION OF THE NEWBORN'S HEALTH. BASED ON THE NOTICED FREQUENCY OF DEFECTIVE WELLS, THE THEORETICAL PROBABILITY OF FALSE NEGATIVE REPORTED IS ESTIMATED TO BE 0.00001% - 0.0003% DEPENDING ON THE INCIDENCE RATE OF THE DISORDER.

    Description of Event or Problem · 1

    THREE CUSTOMER COMPLAINTS HAVE BEEN RECEIVED; 3 IN (B)(6) 2012 AND 1 IN (B)(6) 2012. THE COMPLAINTS ALLEGED EMPTY MICROPLATE WELLS WERE OBSERVED AFTER THE EXTRACTION INCUBATION STEP WHEN USING NEOBASE NON-DERIVATIZED MSMS KIT. THE COMPLAINTS WERE FROM, (B)(6), U.S ABOUT NEOBASE PRODUCT LOT 618494 (RECEIVED ON (B)(6) 2012), (B)(6), U.S ABOUT NEOBASE PRODUCT LOT 617253 (RECEIVED (B)(6) 2012), (B)(6) ABOUT NEOBASE PRODUCT LOT 618763 (RECEIVED (B)(6) 2012). ALL THREE COMPLAINTS ALLEGED OCCASIONAL DRY OR EMPTY WELLS AFTER THE EXTRACTION INCUBATION STEP OF THE NEOBASE ASSAY. THE RESULT IS THAT THE TESTING COULD NOT BE CONTINUED / COMPLETED. NO FALSE NEGATIVE OR FALSE POSITIVE RESULTS ARE KNOWN TO HAVE BEEN REPORTED. DEFECTS IN THE 96-WELL TRUNCATED V-BOTTOMED MICROPLATE IS THE ISSUE. THE MICROPLATE IS A CONSUMABLE PROVIDED WITH THE NEOBASE KIT. THE SAME PLATE IS USED ALSO WITH OTHER PRODUCT AS CONSUMABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBASE NON-DERIVATIZED MSMS KIT NQL WALLAC OY 3040-001U 618494

    Patients

    Seq Age Sex Outcome Treatment
    1