BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBASE NON-DERIVATIZED MSMS KIT

    MDR report key: 4351053 · Received December 12, 2014

    Report

    Report Number
    8043909-2014-00003
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    May 2, 2014
    Report Date
    December 12, 2014
    Manufacturer
    PERKINELMER, WALLAC OY
    Product Code
    NQL
    PMA / PMN Number
    K083130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFG BATCH RECORDS WERE REVIEWED: NO DEVIATIONS WERE FOUND, BOTH ORIGINAL AND RETEST DEVICE LOTS PERFORMED WITHIN ACCEPTANCE RANGE AND THE MEASURED CONCENTRATIONS FOR C3 DID NOT DEVIATE FROM THE OTHER RELEASED KIT LOTS. THE DATA OF CUSTOMER'S ORIGINAL TEST AND RETEST WERE EVALUATED BY BIOSTATISTICIAN AND CUSTOMER SUPPORT SPECIALIST: IN BOTH RUNS THE DEVICE PERFORMANCE WAS ACCEPTABLE, NO DEVIATIONS WERE IDENTIFIED AND QC-CONTROL RESULTS WERE WITHIN +/- 1SD OR +/- 2SD LIMITS. VARIATION BETWEEN 5 RETEST REPLICATES WERE ACCEPTABLE. THE SCREENING PROFILES OF THE ORIGINAL AND RETEST WERE COMPARED: SIGNIFICANT DIFFERENCES BETWEEN C3 AND OTHER ANALYTES WERE OBSERVED. BASED ON THE CONSISTENCY OF THE 5 REPLICATE RESULTS IN RETEST, ASSAY VARIATION CAN BE EXCLUDED AS A CAUSE FOR FALSE NEGATIVE RESULT. PREVENTIVE MAINTENANCE OF THE TEST SYS INSTRUMENTS (WATERS TQD MSMS) IN CUSTOMER LAB HAD BEEN COMPLETED ON TIME, NO REPORTED PROBLEMS WITH THE INSTRUMENTS AT THE TIME OF TESTING. PHOTO OF THE NBS SPECIMEN CARD PROVIDED BY THE (B)(6) LAB SHOWS THAT SOME OF THE ORIGINAL SAMPLE PUNCHES MAY HAVE BEEN INCOMPLETE I.E. SAMPLES MEASURED MAY HAVE CONTAINED LESS BLOOD. THROUGH OUR ANALYSIS AND INVESTIGATION NO MALFUNCTION OR DEFICIENCY OF PRODUCT COULD BE IDENTIFIED. POTENTIAL CAUSE FOR FALSE NEGATIVE IS THAT THE SAMPLES IN THE RETEST WERE NOT FROM THE SAME SPECIMEN AS IN THE ORIGINAL TEST. THE NEOBASE NON-DERIVATIZED MSMS TEST SYSTEM IS INTENDED FOR THE MEASUREMENT AND EVAL OF AMINO ACIDS, SUCCINYLACETONE, FREE CARNITINE, AND ACYLCARNITINE CONCENTRATIONS FROM NEWBORN HEEL PRICK BLOOD SAMPLES DRIED ON FILTER PAPER. QUANTITATIVE ANALYSIS OF THESE ANALYTES (LIST OF ANALYTES IS EXTENSIVE AND CAN BE PROVIDED UPON REQUEST OR REFER TO CLEARANCE LETTER FOR (B)(4)) AND THEIR RELATIONSHIP WITH EACH OTHER IS INTENDED TO PROVIDE ANALYTE CONCENTRATION PROFILES THAT MAY AID IN SCREENING NEWBORNS FOR METABOLIC DISORDERS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 PERKINELMER RECEIVED A COMPLAINT CONCERNING THE NEOBASE NON-DERIVATIZED MSMS TEST SYS FROM THE (B)(6) REGARDING A FALSE NEGATIVE SCREENING RESULT FOR A NEWBORN WHO LATER CONFIRMED FOR METHYLMALONIC ACIDEMIA (MMA). THE NEWBORN WAS BORN (B)(6) 2013, THE NEWBORN SCREENING (NBS) SPECIMEN WAS TAKEN AT THE AGE OF 27 HOURS ON (B)(6) 2013 AND TESTED (B)(6) 2013. THE REPORTED RESULTS ON (B)(6) 2013 INDICATED LOW RISK TO ALL SCREENED DISORDERS INCLUDING MMA. THE SPECIFIC PRIMARY MARKER FOR MMA IS ACYLCARNITINE C3. AT THE AGE OF 10 MONTHS THE BABY WAS REFERRED TO (B)(6) FOR EVAL DUE TO CLINICAL SYMPTOMS AND MMA DIAGNOSIS WAS CONFIRMED BY DNA TEST. (B)(6) LAB BECAME AWARE OF THE BABY'S MMA DIAGNOSIS ON (B)(6) 2014. THE (B)(6) LAB RETESTED THE RETAINED, ORIGINAL NBS SPECIMEN IN 5 REPLICATES. THE MEASURED C3 CONCENTRATION FOR ALL THE FIVE REPLICATES WAS ELEVATED AND INDICATED AN ELEVATED RISK FOR MMA. THE (B)(6) LAB FILED A COMPLAINT WITH (B)(6) ON (B)(6) 2014 AND PROVIDED THE RESULTS OF ORIGINAL RETESTS OF THE SPECIMEN FOR EVAL. WE HAVE CONFIRMED WITH THE (B)(6) LAB THAT THE NEWBORN IS RESPONSIVE TO VITAMIN B12-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818251 NEOBASE NON-DERIVATIZED MSMS KIT TANDEM MASS SPECTROMETRY ASSAY NQL PERKINELMER, WALLAC OY 3040-001U 622128

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention