BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTODELFIA NEONATAL KIT

    MDR report key: 2322939 · Received November 1, 2011

    Report

    Report Number
    8043909-2011-00001
    Event Type
    Other
    Date Received
    November 1, 2011
    Date of Event
    June 11, 2011
    Report Date
    October 27, 2011
    Manufacturer
    PERKINELMER
    Product Code
    KHO
    PMA / PMN Number
    K935047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTODELFIA NEONATAL HTSH KIT LOT 606475 FROM MFR'S RETAIN STOCK WAS TESTED ON (B)(6) 2011 AND THE RESULTS WERE WITHIN THE SPECIFICATIONS FOR RELEASE TEST. WHEN COMPARED WITH THE ORIGINAL QC TEST RESULTS (B)(6) 2011, NO SIGNIFICANT DIFFERENCE WAS IDENTIFIED, WHICH INDICATES NO REASON TO SUSPECT THE STABILITY OF THE PRODUCT. ALSO (B)(6) REPORTED THE KIT PERFORMANCE BEING ACCEPTABLE ACCORDING TO THEIR QC CRITERIA. THE POSSIBILITY OF SAMPLE INTERFERENCE WAS IDENTIFIED AS THE MOST PROBABLE CAUSE FOR THE FALSELY LOW TSH RESULT. NO REPORTS OF THE INTERFERING EFFECT OF AMPICILLIN OR OTHER ANTIBIOTICS ON TSH OR IMMUNOASSAYS WERE IDENTIFIED. THE POTENTIAL INTERFERING SUBSTANCES ARE EDTA AND CITRATE (DECREASING EFFECT) OR HETEROPHILIC AND HAMA ANTIBODIES (TYPICALLY INCREASING EFFECT). THE WARNING OF THE POTENTIAL INTERFERENCE OF THESE FACTORS IS GIVEN IN THE KIT INSERT. (B)(6) LAB HAS INSTRUCTED HOSPITALS NOT TO USE EDTA OR CITRATE BLOOD WHEN COLLECTING NBS SPECIMEN, HEEL PRICK METHOD RECOMMENDED. ON (B)(6) 2011, (B)(6) INFORMED VENOUS BLOOD HAD BEEN USED AND THAT IT WAS NOT POSSIBLE TO EXCLUDE THE USE OF EDTA OR CITRATE. DUE TO THE CONFIDENTIALITY OF PT RECORDS THE POTENTIAL FACTORS CAUSED BY MOTHER'S STATE OF HEALTH OR MEDICATION COULD NOT BE EVALUATED. IT CAN BE CONCLUDED THAT THE QUALITY OF AUTODELFIA NEONATAL TSH KIT LOT 606475 HAS NOT CAUSED THE FALSELY LOW TSH RESULT. THE CAUSE FOR THE FALSELY LOW TSH RESULT CAN ONLY BE CONSIDERED, BUT NOT VERIFIED AS THE ORIGINAL SPECIMEN HAS BEEN DESTROYED AND DETAILED INFO ABOUT THE SPECIMEN COLLECTION AND PT RECORDS IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(4) RECEIVED A COMPLAINT FROM (B)(6) ABOUT A FALSELY LOW TSH IN NEWBORN SCREENING (NBS). THE BABY GIRL WAS BORN ON (B)(6) 2011, AS A FULL TERM BABY AND DUE TO A SUSPICION OF RESPIRATORY INFECTION, ANTIBIOTIC TREATMENT WAS STARTED RIGHT AFTER BIRTH. THE NBS SPECIMEN WAS COLLECTED AT THE AGE OF (B)(6) HOURS AND THE SCREENING TESTS WERE DONE ON (B)(6) 2011, ACCORDING TO (B)(6). ALL SCREEN RESULTS WERE NEGATIVE AND THE BABY WAS RELEASED WITHOUT COMPLICATIONS. ON (B)(6) 2011, THE BABY WAS ADMITTED A SECOND TIME FOR FAILURE TO THRIVE AND WAS TESTED FOR ENDOCRINE FUNCTION. ON (B)(6) 2011, THE LAB RESULTS FOR SERUM TSH AND FT4 CONFIRMED PRIMARY HYPOTHYROIDISM (CH) AND THYROXINE TREATMENT WAS STARTED. THE THYROID SCAN ON (B)(6) 2011, SHOWED NO THYROID GLAND, BUT ONLY A KIND OF TISSUE MASS. THE BABY WAS ALSO VERIFIED ANEMIC. ON (B)(6) 2011, HOSPITAL INFORMED THE BABY WAS DOING GREAT. AS THE NBS SCREEN WAS NEGATIVE THE ORIGINAL SPECIMEN WAS DESTROYED (B)(6) DAYS AFTER BIRTH, ACCORDING TO STATE LAW. THE SCREEN RESULT COULD NOT BE RETESTED NOR THE PRESENCE OF INTERFERING SUBSTANCE INVESTIGATED OR VERIFIED AS THE SPECIMEN WAS NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODELFIA NEONATAL KIT TIME-RESOLVED FLUOROIMMUNOASSAY FOR TSH KHO PERKINELMER B032-312 606475

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention