BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 8868279 · Received August 7, 2019

    Report

    Report Number
    9610824-2019-00039
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 5, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL 1&2 ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. THE CUSTOMER STATED THAT THE ANTIBODY COULD BE DETECTED IN THE ORTHO GEL METHOD. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 1&2. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT PRODUCT SAMPLE RETURNED BY THE CUSTOMER AND COULD CONFIRM THE CUSTOMER´S FINDING. FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE WERE NOT POSSIBLE, BECAUSE IT WAS USED UP. THE RETURNED PRODUCT SAMPLE AND OUR QC LAB'S RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WERE TESTED WITH DIFFERENT SAMPLES AND CONTROLS INCLUDING AN ANTI-E ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO INFINITY: THE CUSTOMER PROVIDED RESULT IMAGES THAT SHOW THE NEGATIVE ANTIBODY SCREENING RESULT FOR AN ANTI-E, WHICH CAN BE ALSO VISUALLY CONFIRMED. LAST SEMI-ANNUAL PREVENTIVE MAINTENANCE WAS PERFORMED AS PER CHECKLIST ON APRIL 02, 2019. A FIELD SERVICE ENGINEER INSPECTED THE AFFECTED INSTRUMENT. ACCORDING TO THE FIELD SERVICE REPORT (WO REPORT) FROM JULY 11, 2019, ALL REQUESTED FILES WERE COLLECTED. THE PC WAS REBOOTED AND FIREWALL BOX TO RECONNECT BRICARE. IT WAS VERIFIED WITH A BRICARE ENGINEER THAT THE CONNECTION WAS WORKING. THE INSTRUMENT WAS OPERATING WITHIN MANUFACTURER SPECIFICATIONS AND RETURNED TO FULL SERVICE. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. NO INDICATION FOR AN INSTRUMENT MALFUNCTION COULD BE IDENTIFIED ON CURRENT DATA. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT. AS TO DATABASE, NO PROBLEMS WITH QUALITY CONTROL TESTING ON SOLIDSCREEN II METHOD ON THE DAYS OF ISSUE OCCURRED. THE CONTROL SAMPLES DID PASS EVERY DAY. THE INSTRUMENT GAVE REPEATEDLY THE SAME RESULTS AND THE REPORTED PROBLEM IS LIKELY RELATED TO SAMPLE SPECIFICITIES. THE ANTIBODIES WITHIN AFFECTED SAMPLE MAY HAVE BEEN PRESENT IN TOO LOW CONCENTRATION (BOARDERLINE) TO BE EVALUATED AS POSITIVE REACTION BY THE SOLIDSCREEN II METHOD. THE USAGE OF DIFFERENT METHODS MAY RESULT IN DIFFERENT RESULTS FOR THE ANTI-E ANTIBODY, BECAUSE IT IS A WEAK REACTING ANTIBODY AND THE METHODS HAVE DIFFERENT DETECTION SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666604 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8923011-00 07611969952380

    Patients

    Seq Age Sex Outcome Treatment
    1