BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 6840944 · Received September 4, 2017

    Report

    Report Number
    9610824-2017-00061
    Event Type
    Malfunction
    Date Received
    September 4, 2017
    Date of Event
    August 3, 2017
    Report Date
    October 27, 2017
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969951147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE KNOWN AS B RH(D) POSITIVE SHOWED FALSE NEGATIVE REACTIONS WITH ANTI-D OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT HAS BEEN TRANSFUSED WITH ONE UNIT OF O RH(D) NEGATIVE AND ONE UNIT OF B RH(D) NEGATIVE BLOOD CELLS. THE PATIENT SAMPLE RAN ON THE TANGO INFINITY TWICE POST THE TRANSFUSION. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A POSITIVE REACTION (4+/ MIXED FIELDS) WITH ANTI D IN TUBE TESTING. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE RESULTS. OUR QUALITY CONTROL LABORATORY TESTED AS FOLLOWS: THE ALLEGEDLY DEFECTIVE PLATES WERE TESTED WITH DIFFERENT DONOR SAMPLES AND THE PROVIDED PATIENT SAMPLE (#: (B)(6)) ON TANGO INFINITY. ADDITIONALLY, A DWEAK TYP 3 SAMPLE WAS TESTED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. UPON ARRIVAL AT BIO-RAD, THE PATIENT SAMPLE WAS ALREADY HEMOLIZED BUT IT WAS CLEARLY IDENTIFIED AS B RH(D) POSITIVE. PLATE 023963 (S ABD REV.A1,B) YIELDED 4+ REACTIONS WITH BOTH ANTI-D´S, PLATE 0961 (S RHD CONFIRM) YIELDED A 4+ REACTION AND PLATE 02958 (S ABD REV.A1,B) GAVE 3+ REACTIONS WITH BOTH ANTI-D´S. NO MIXED FIELD REACTION WERE VISIBLE. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE HAD A NEGATIVE INFLUENCE ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE COMPLAINT WAS CLASSIFIED AS "NOT CONFIRMED" BECAUSE IT WAS NOT POSSIBLE TO RECONSTRUCT THE CASE. THE PATIENT SAMPLE REACTED CLEARLY POSITIVE AND THE PLATES PROVIDED BY THE CUSTOMER WORKED AS EXPECTED. THE AFFECTED TANGO INFINITY WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS. NO INDICATION FOR AN INSTRUMENT MALFUNCTION COULD BE IDENTIFIED. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT BY METROLOGY QUALIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE KNOWN AS B RH(D) POSITIVE SHOWED FALSE NEGATIVE REACTIONS WITH ANTI-D OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT HAS BEEN TRANSFUSED WITH ONE UNIT OF O RH(D) NEGATIVE AND ONE UNIT OF B RH(D) NEGATIVE BLOOD CELLS. THE PATIENT SAMPLE RAN ON THE TANGO INFINITY TWICE POST THE TRANSFUSION. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A POSITIVE REACTION (4+/ MIXED FIELDS) WITH ANTI D IN TUBE TESTING THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE LOT OF THE PRODUCT ERYTYPE S ABD + REV. A1,B AND THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULTS (DATE OF RECEIPT (B)(6) 2017) . THE INVESTIGATIONS OF OUR QUALITY CONTROL LABORATORY ARE STILL ONGOING. FROM TODAY´S PERSPECTIVE THE AFFECTED TANGO INFINITY WAS CONFIRMED TO RUN WITHIN SPECIFICATIONS. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES ON THE DATES OF TESTING, THE ROOT CAUSE ANALYSIS IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620963 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+REV A1,B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8646110 07611969951147

    Patients

    Seq Age Sex Outcome Treatment
    1