BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK

    MDR report key: 4193846 · Received October 22, 2014

    Report

    Report Number
    1319808-2014-00026
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS EVENT. THE AFFECTED RESULTS WERE ISOLATED TO THE TWO REAGENT PACKS IN USE. THEREFORE, INCONSISTENT REAGENT PACK HANDLING OR AN UNIDENTIFIED ISSUE ASSOCIATED WITH EACH OF THE TWO VALP REAGENT PACKS CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THERE WAS NO INDICATION THAT THE VITROS 5600 INTEGRATED SYSTEM MALFUNCTIONED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM USING 2 DIFFERENT VITROS VALP LOT 2511-22-3413 REAGENT PACKS (PACK 207 AND 208). BIORAD- LEVEL 1= 24.6 AND 22.9 UG/ML VERSUS EXPECTED 36.2 UG/ML; BIORAD- LEVEL 2= 61.7 AND 56.1 UG/ML VERSUS EXPECTED 79.9 UG/ML; BIORAD- LEVEL 3= 91.7 AND 96.2 UG/ML VERSUS EXPECTED 123.9 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE KNOWN TO HAVE BEEN AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672271 VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-22-3413

    Patients

    Seq Age Sex Outcome Treatment
    1