BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS

    MDR report key: 19805759 · Received July 23, 2024

    Report

    Report Number
    9610824-2024-00030
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 22, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952441
    PMA / PMN Number
    125207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PATIENT SAMPLE THAT HAD A POSITIVE ANTIBODY SCREEN ON TANGO INFINITY WHEN USING BIOTESTCELL 3. THE SCREENING WAS REPEATED AND YIELDED A NEGATIVE. RESULT. TESTING WAS REPEATED THE NEXT DAY USING THE SAME TANGO INFINITY AND THE SAME BIOTESTCELL 3 VIAL. ALL CELLS WERE NEGATIVE (PLEASE ALSO SEE RELATED REPORTS 9610824-2024-00028 AND 9610824-2024-00029) . FURTHERMORE ALL PANEL CELLS USING BIOTESTCELL I-11 PLUS WERE NEGATIVE. A CONSULTED REFERENCE LABORATORY IDENTIFIED A WARM AUTO ANTIBODY. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFECTED LOT OF BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL DEPARTMENT TESTED TWO KNOWN ANTIBODIES (ANTI-K, ANTI-C), A POSITIVE CONTROL (SOLID SCREEN II CONTROL) AND A NEGATIVE CONTROL (SOLID SCREEN II NEGATIVE CONTROL) WITH BIOTESTCELL I-11 PLUS.. ALL REACTIONS OF THE REAGENT RED BLOOD CELLS WERE CLEARLY POSITIVE WITH THE CORRESPONDING ANTIBODY. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTIGATION OF THE AFFECTED TANGO INFINITY INSTRUMENT IS STILL ONGOING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE HAD A POSITIVE ANTIBODY SCREEN ON TANGO INFINITY WHEN USING BIOTESTCELL 3. THE SCREENING WAS REPEATED AND YIELDED A NEGATIVE. RESULT. TESTING WAS REPEATED THE NEXT DAY USING THE SAME TANGO INFINITY AND THE SAME BIOTESTCELL 3 VIAL. ALL CELLS WERE NEGATIVE (PLEASE ALSO SEE RELATED REPORTS 9610824-2024-00028 AND 9610824-2024-00029) . FURTHERMORE ALL PANEL CELLS USING BIOTESTCELL I-11 PLUS WERE NEGATIVE. A CONSULTED REFERENCE LABORATORY IDENTIFIED A WARM AUTO ANTIBODY. OUR QUALITY CONTROL DEPARTMENT TESTED TWO KNOWN ANTIBODIES (ANTI-K, ANTI-C), A POSITIVE CONTROL (SOLIDSCREEN II CONTROL) AND A NEGATIVE CONTROL (SOLIDSCREEN II NEGATIVE CONTROL) WITH THEIR RETENTION SAMPLE OF BIOTESTCELL I-11 PLUS AND THE CURRENT LOT OF BIOTESTCELL-3. ALL REACTIONS OF THE REAGENT RED BLOOD CELLS WERE CLEARLY POSITIVE WITH THE CORRESPONDING ANTIBODY. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE ANY FALSE NEGATIVE OR FALSE POSITIVE RESULTS WITH THE ALLEGEDLY DEFECTIVE PRODUCTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER PROVIDED A PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. ONCE IT ARRIVED ON OUR PREMISES, IT WAS TESTED WITH CURRENT LOTS OF BIOTESTCELL 3 AND BIOTESTCELL-I 11 PLUS ON TANGO INFINITY, BECAUSE THE COMPLAINED LOTS WERE ALREADY EXPIRED. ALL RESULTS WERE NEGATIVE. ADDITIONALLY AN ANTIBODY SCREEN TESTING WITH IH-CELL I-II-III WAS MANUALLY PERFORMED, AS WELL AS A DAT AND AN AUTOCONTROL. THE DAT WAS NEGATIVE AND THE AUTOCONTROL YIELDED A WEAK POSITIVE REACTION. ON TANGO INFINITY BOTH RESULTS (DAT AND AUTOCONTROL) CAME UP AS NEGATIVE. INSTRUMENT DATA OF THE AFFECTED TANGO INFINITY INSTRUMENT WERE ANALYZED. THIS ANALYSIS THE ANALYSIS DID NOT SHOW ANY SIGNS OF AN INSTRUMENT MALFUNCTION WHICH WOULD EXPLAIN THE DISCREPANCY BETWEEN THE FIRST ABSCREENING TEST AND THE PANEL TESTS. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - EPP (EXPECTED PRODUCT PERFORMANCE): THE RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT WAS TESTED WITHIN ITS SHELF-LIFE AND REACTED AS EXPECTED. THE COMPLAINED SAMPLE BIOTESTCELL-I 11 PLUS WAS NOT AVAILABLE FOR INVESTIGATION. WE WERE NOT ABLE TO DETECT AN ANTIBODY ON THE PROVIDED PATIENT SAMPLE ON TANGO INFINITY. THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER SHOWED COMPLETELY NEGATIVE RESULTS ON TANGO INFINITY, BUT A WEAK POSITIVE RESULT WAS FOUND AT THE AUTOCONTROL WITH THE IH-CARD METHOD. THE PATIENT SAMPLE WAS THEN USED UP AND NO FURTHER TESTING WAS POSSIBLE. THE ANALYSIS OF THE INSTRUMENT DATA DID NOT SHOW ANY SIGNS OF AN INSTRUMENT MALFUNCTION. THE REPORTED PROBLEM IS LIKELY RELATED TO SAMPLE SPECIFICITIES. THE INSTRUCTION FOR USE CONTAINED AN APPROPRIATE NOTE IN THE SECTION LIMITATIONS: "NEGATIVE REACTIONS WILL BE OBTAINED IF THE SAMPLE CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED. NO TEST METHOD IS CAPABLE OF DETECTING ALL RED CELL ANTIBODIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440168 REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS BIOTESTCELL-I 11 PLUS QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 9422011-00 07611969952441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BIOTESTCELL 3, LOT 9418021-00.| BIOTESTCELL 3, LOT 9418021-00.| TANGO INFINITY, SN: (B)(6).| TANGO INFINITY, SN: (B)(6).