BEUDAMED
    FDA Adverse Event Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS IPTH REAGENT

    MDR report key: 3927448 · Received July 10, 2014

    Report

    Report Number
    3007111389-2014-00150
    Date Received
    July 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED REPRODUCIBLE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE OBTAINED FROM MULTIPLE SAMPLES COLLECTED FROM A SINGLE PATIENT SAMPLE, WHEN PROCESSED ON TWO DIFFERENT VITROS ECIQ SYSTEMS. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT OR REAGENT MALFUNCTION HAD OCCURRED. TREATING THE SAMPLE USING A HETEROPHILIC BLOCKING TUBE YIELDED LOWER RESULTS THAN THE UNTREATED SAMPLE. THE MOST LIKELY CAUSE OF THE EVENT IS THE PRESENCE OF HETEROPHILIC ANTIBODIES IN THE PATIENT SAMPLE THAT ARE INTERFERING WITH THE ASSAY. THE VITROS IPTH ASSAY IS KNOWN TO BE SUSCEPTIBLE TO HETEROPHILIC ANTIBODY INTERFERENCE AS, PER THE PRODUCT'S INSTRUCTIONS FOR USE: HETEROPHILIC ANTIBODIES IN SERUM OR PLASMA SAMPLES MAY CAUSE INTERFERENCE IN IMMUNOASSAYS. THESE ANTIBODIES MAY BE PRESENT IN BLOOD SAMPLES FROM INDIVIDUALS REGULARLY EXPOSED TO ANIMALS OR WHO HAVE BEEN TREATED WITH ANIMAL SERUM PRODUCTS. RESULTS WHICH ARE INCONSISTENT WITH CLINICAL OBSERVATIONS INDICATE THE NEED FOR ADDITIONAL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS IPTH VALUES OBTAINED FROM MULTIPLE SAMPLES COLLECTED FROM A SINGLE PATIENT TESTED ON TWO DIFFERENT VITROS INSTRUMENTS (5600 INTEGRATED SYSTEM AND ECIQ IMMUNODIAGNOSTIC SYSTEM) WHEN COMPARED TO RESULTS OBTAINED FROM A NON-VITROS METHOD THAT WERE CONSIDERED TO BE WITHIN THE ¿NORMAL¿ RANGE FOR IPTH. SAMPLE, DATE , VITROS IPTH RESULT, 1, (B)(6) 2014, 405 PG/ML. 2, (B)(6) 2014, 380 PG/ML. 3, (B)(6) 2014, 455 PG/ML. 4, (B)(6) 2014, 455 PG/ML. 5, (B)(6) 2014, 380 PG/ML. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS LISTED ABOVE WERE EXPECTED BY THE CUSTOMER TO BE WITHIN THE VITROS IPTH REFERENCE INTERVAL OF 7.5 TO 53.5 PG/ML. THE HIGHER THAN EXPECTED VITROS IPTH RESULTS WERE REPORTED TO HEALTH CARE PROVIDERS AND BASED ON THE HIGHER THAN EXPECTED REPORTED RESULTS, THE PATIENT UNDERWENT PARATHYROID SURGERY. THERE WAS NO REPORTED ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405145 VITROS IMMUNODIAGNOSTICS PRODUCTS IPTH REAGENT IN-VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 0480

    Patients

    Seq Age Sex Outcome Treatment
    1