BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 2191734 · Received August 4, 2011

    Report

    Report Number
    1319809-2011-00122
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM PATIENT SAMPLES THAT WERE STORED IN SERUM COLLECTION DEVICES CONTAINING A GEL SERUM SEPARATION BARRIER (VACUTAINER SSTTM) FOR AN EXTENDED PERIOD THAT WAS NOT IN ACCORDANCE WITH THE VITROS PHYT INSTRUCTIONS FOR USE. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST AN INSTRUMENT OR REAGENT MALFUNCTION HAD OCCURRED. THE CAUSE OF THIS EVENT IS PRE-ANALYTICAL USER ERROR DUE TO IMPROPER PATIENT SAMPLE HANDLING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS FROM MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED. PATIENT 1, SAMPLE 1: 6.7 AND <3.0 UG/ML VS. 13.8 UG/ML. PATIENT 1, SAMPLE 2: 7.2 UG/ML VS. 12.0 UG/ML. PATIENT 1, SAMPLE 3: 7.6 UG/ML VS. 12.8 UG/ML. THE LOWER THAN EXPECTED RESULTS WERE NOT REPORTED FROM THE LABORATORY. HOWEVER, BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2649-0121-1464

    Patients

    Seq Age Sex Outcome Treatment
    1