BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 3204089 · Received July 3, 2013

    Report

    Report Number
    1319808-2013-00036
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPRODUCIBLE, LOWER THAN EXPECTED, VITROS VANC RESULTS WERE OBSERVED WHEN COMPARED TO A NON-VITROS METHOD USING TWO DIFFERENT VITROS VANC LOTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM AND AN ALTERNATE VITROS SYSTEM. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ASSIGNABLE CAUSE IS AN UNKNOWN SAMPLE INTERFERENT. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED REPRODUCIBLE, LOWER THAN EXPECTED, VITROS VANC RESULTS FROM A SINGLE PATIENT SAMPLE WHEN COMPARED TO A NON-VITROS METHOD USING TWO DIFFERENT VITROS VANC LOTS ON A VITROS 5, 1 FS CHEMISTRY SYSTEM AND AN ALTERNATE VITROS SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: VITROS VANC LOT 2514-25-2897: VITROS 5, 1 FS CHEMISTRY SYSTEM: SAMPLE 2 = <5.0, <10.0, <5.0 VS. AN EXPECTED RESULT = 121.9 ¿G/ML; UNCONFIRMED VITROS SYSTEM SAMPLE 2 = <5.0 VS. AN EXPECTED RESULT = 121.9 ¿G/ML; VITROS VANC LOT 2514-26-2987: VITROS 5, 1 FS CHEMISTRY SYSTEM: SAMPLE 3 = < 5.0 VS. AN EXPECTED RESULT =53.3 ¿G/ML; THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER RETESTED THE SAMPLE USING A NON-VITROS METHOD AS THE PHYSICIAN QUESTIONED THE AFFECTED SAMPLE RESULT. A CORRECTED REPORT WAS ISSUED. TREATMENT WAS ADMINISTERED TO THE PATIENT BASED ON THE AFFECTED RESULTS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305543 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS 2514-25-2897

    Patients

    Seq Age Sex Outcome Treatment
    1