BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 3913128 · Received July 3, 2014

    Report

    Report Number
    3007111389-2014-00146
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A HIGHER THAN EXPECTED VITROS IPTH RESULT WAS OBTAINED FROM A NON OCD QUALITY CONTROL FLUID PROCESSED ON THE VITROS 5600 SYSTEM. A REVIEW OF HISTORICAL QUALITY CONTROL DATA INDICATED A REAGENT ISSUE COULD NOT BE RULED OUT. SERVICE ACTIONS WERE PERFORMED TO OPTIMIZE SYSTEM PERFORMANCE. HOWEVER, PRE-SERVICE WITHIN RUN PRECISION TESTING WAS NOT PERFORMED TO ESTABLISH INSTRUMENT PERFORMANCE PRIOR TO SERVICE. ADDITIONALLY, FOLLOWING SERVICE ACTIONS, THE CUSTOMER MOVED TO A DIFFERENT LOT OF VITROS IPTH REAGENT. THERE IS NO INFORMATION AVAILABLE TO CORRELATE THAT AN INSTRUMENT ISSUE(S) ADDRESSED BY THE SERVICE ACTIONS MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE AN INSTRUMENT RELATED ISSUE CANNOT BE RULED. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULT FROM A NON OCD QUALITY CONTROL SAMPLE PROCESSED ON A VITROS 5600 SYSTEM (VITROS IPTH = 274.0 PG/ML VS. EXPECTED RESULT OF 209.6 PG/ML). THERE WAS NO ALLEGATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED. HOWEVER, BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. THERE WAS NO ALLEGATION PATIENT HARM.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389340 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTIC CEW ORTHO-CLINICAL DIAGNOSTICS 440

    Patients

    Seq Age Sex Outcome Treatment
    1