BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 11403340 · Received March 3, 2021

    Report

    Report Number
    9610824-2021-00006
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969951147
    PMA / PMN Number
    125094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SOME DOTS OR RESIDUALS IN THE WELLS OF ERYTYPE S ABD+REV.A1, B. THE OBSERVED DOTS CAUSED FALSE POSITIVE RESULTS ON TANGO INFINITY. BECAUSE THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF ERYTYPE S ABD+REVA1,B FOR INVESTIGATINAL TESTING, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND ERYTYPECELL A1&B LOT #9102011-00 AND #9106011-00 WITH DIFFERENT DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY DOTS OR RESIDUALS. ALL NEGATIVE REACTIONS WERE CLEARLY NEGATIVE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO INFINITY WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. THE INFORMATION PROVIDED BY THE FIELD SERVICE ENGINEER CONFIRMED THAT THE INSTRUMENT WAS WITHIN MANUFACTURER MEANS AND WAS RETURNED TO THE CUSTOMER FOR NORMAL USE. ACCORDING TO THE FIELD SERVICE ENGINEER, THE CUSTOMER LET THE ERYTYPE PLATES NOT COME TO ROOM TEMPERATURE BEFORE LOADING ON THE INSTRUMENT. THE CUSTOMER WAS INFORMED THAT THEY SHOULD LET THE PLATES COME TO ROOM TEMPERATURE BEFORE OPENING THE PACKAGE AND LOADING THE PLATE ONTO THE TANGO INFINITY.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INTIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DOTS OR RESIDUALS IN THE WELLS OF ERYTYPE S ABD+REV.A1, B, THAT GAVE AN ERROR WITH THE REACTION RESULT WHEN USED ON TANGO INFINITY. THE CUSTOMER DID NEITHER THE SAMPLES NOR THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY IS ALSO STILL WAITING FOR FURTHER INFORMATION REGARDING THE CUSTOMER'S COMPLAINT AND ALSO FOR IMAGINES THAT CAN DEMONSTRATE THE ISSUE. WHILE WAITING FOR THE MISSING INFORMATION, IMAGINES AND THE COMPLAINT SAMPLES, OUR QUALITY CONTROL LABORATORY STARTED TESTING THEIR RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV.A1,B. THIS TESTING IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302455 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+REV A1,B QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8950190 07611969951147

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO INFINIY, SN (B)(6)| TANGO INFINIY, SN (B)(6)