BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    MDR report key: 9178405 · Received October 11, 2019

    Report

    Report Number
    9610824-2019-00056
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FALSE NEGATIVE RESULTS ON HER TANGO INFINITY WHEN USING BIOTESTCELL-I11. THE CUSTOMER STATED THAT WITHIN HER VALIDATION OF HER NEW TANGO INFINITY A SAMPLE WITH AN ANTI-FY(B) SHOWED FALSE NEGATIVE RESULTS WITH BIOTESTCELL-I11. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME THE CUSTOMER FILED HER COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WAS NOT TESTED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE DID NOT RECEIVE ANY FURTHER COMPLAINTS RELATED TO THIS ISSUE. REGARDING THE AFFECTED TANGO INFINITY: RESULT IMAGES FROM AVAILABLE SAMPLES WERE REVIEWED (SOURCED FROM SENT DATABASE VALIDATE.PHB = LAB JOURNAL). THE IMAGES FROM COMPLAINT SAMPLES ARE SHOWING NEGATIVE RESULTS, WHICH CAN BE VISUALLY CONFIRMED AS NEGATIVE. THE INSTRUMENT WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND LOG FILES COLLECTED. METROLOGY WAS RUN AND VERIFIED THAT ALL WERE WITHIN MANUFACTURER RANGES. METROLOGY QUALIFICATION WAS PERFORMED WITH PASSING QC. THE ANTIBODIES WERE ORIGINALLY DETECTED IN ORTHO GEL AND SOME SAMPLES WERE REPEATED IN GEL AFTER INFINITY TESTING. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. THE CONTROL DATABASE DID NOT CONTAIN ANY WEAKENING SOLIDSCREEN II QC. 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 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 WEAK REACTING ANTIBODIES AND THE METHODS HAVE DIFFERENT DETECTION SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976902 REAGENT RED BLOOD CELLS BIOTESTCELL-I11 BIOTESTCELL-I11 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8929011-00 07611969952434

    Patients

    Seq Age Sex Outcome Treatment
    1