BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3485674 · Received November 25, 2013

    Report

    Report Number
    1056600-2013-00072
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    September 26, 2013
    Report Date
    November 25, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, HOW EVER THE WORK PERFORMED BY THE OCD FE ON SITE THAT WAS DOCUMENTED IN SERVICE ORDERS 1850133 AND 1850692 HAVE REPAIRED AND RETURNED THE PROVUE TO EXPECTED OPERATION. QC HAS SINCE PASSED AFTER THE SERVICE CALLS WERE COMPLETE. NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT. THERE WAS NO HARM TO ANY PATIENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE PROVUE HAS REPORTED NEGATIVE RESULTS WHEN POSITIVE RESULTS WERE EXPECTED, BASED ON RESULTS OBTAINED FROM THEIR OTHER PROVUE. CUSTOMER STATES HER CONFIDENCE IN THE PROVUE HAS DIMINISHED AND SHE REQUESTS SERVICE WITH OUT FURTHER TROUBLESHOOTING. THE PROVUE WILL BE TAKEN OUT OF SERVICE UNTIL A FIELD ENGINEER CHECKS THE PROVUE. CUSTOMER BRIEFLY DESCRIBES 2 EVENTS WHERE THE RESULTS WERE NEGATIVE. BOTH EVENTS WERE DONE BY DIFFERENT TECHNOLOGISTS. THE SAME LOT NUMBERS WERE USED, BUT DIFFERENT SETS WERE ON EACH OF THE PROVUES. CUSTOMER STATES THE TESTINGS WERE DONE AS SINGLE TESTS ON THE PROVUES, NOT IN BATCHES. ALL QUALITY CONTROL RESULTS WERE ACCEPTABLE. THE FIRST EVENT WAS ON (B)(6) 2013 DURING TESTING OF A CAP PROFICIENCY JAT-C WHERE SAMPLE 18 WAS CROSSMATCHED WITH DONOR SAMPLE 20. THIS PROVUE PRODUCED A NEGATIVE (COMPATIBLE) RESULT BUT THE OTHER PROVUE, (B)(4) GAVE A POSITIVE (INCOMPATIBLE) RESULT WHICH WAS CORRECT. REFER TO QERTS 307193 FOR THE ASSESSMENT OF THE SECOND REPORTABLE EVENT INVOLVING A PATIENT SAMPLE THAT WAS REPORTED TO BE FALSE NEGATIVE BASED OFF HISTORY OF KNOWN ANTIBODIES AND WAS EXPECTED TO REACT WITH ALL 3 SCREENING CELLS. ISSUE STARTED ON: (B)(6) 2013, FREQUENCY: 2 EVENTS. SAMPLE ID: NOT PROVIDED, ERROR OCCURRED DURING: ROUTINE USE. CTS REQUESTED ADDITIONAL INFORMATION, CUSTOMER DOES NOT HAVE DETAILED INFORMATION AND REQUESTS SERVICE BE DISPATCHED TO CHECK THE DIAGNOSTICS OF THE PROVUE DUE TO THESE 2 EVENTS. CTS REQUESTED PROVUE REPORTS BE FAXED. CUSTOMER HAS NOT DONE SO BUT WILL BE ATTACHED TO THIS HEADER WHEN IT IS RECEIVED. CUSTOMER PROVIDED PO# 595-C40066 FOR SERVICE. CTS DISPATCHED SERVICE AS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613388 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS MTS213784

    Patients

    Seq Age Sex Outcome Treatment
    1