BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    MDR report key: 10475479 · Received September 1, 2020

    Report

    Report Number
    9610824-2020-00054
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 1, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CELL #1 (DONOR #: (B)(6)) OF BIOTESTCELL-I11 WITH THE ANTI-LE(B) REAGENT OF A COMPETITOR. ACCORDING TO THE ANTIGEN WORKSHEET CELL #1 IS LEA-B+. THE CUSTOMER STATED THAT SHE USED CELL #1 AS A POSITIVE CONTROL FOR THE ANTI-LE(B) REAGENT OF THE COMPETITOR. THE CUSTOMER STATED THAT CELL #2 (DONOR (B)(6)) OF BIOTESTCELL 1&2, WHICH IS ALSO LE(B) POSITIVE YIELDED A CORRECT POSITIVE RESULT. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE BIOTESTCELL-I11 FOR INVESTIGATIONAL TESTING BUT NOT THE ANTI-LE(B) REAGENT OF THE COMPETITOR. AT THE TIME WE RECEIVED THE COMPLAINT SAMPLE THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE WITH SERACLONE ANTI-LE(B). THE TEST WAS PERFORMED MANUALLY IN THE TUBE TECHNIQUE WITH AN INCUBATION OF 15 MINUTES AT ROOM TEMPERATURE ACCORDING TO THE INSTRUCTION FOR USE OF SERACLONE ANTI-LE(B). CELL #1 OF BIOTESTCELL-I11 YIELDED A CORRECT POSITIVE RESULT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 FUNCTIONS CORRECTLY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944962 REAGENT RED BLOOD CELLS BIOTESTCELL-I11 BIOTESTCELL-I11 QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 8025021-00 07611969952434

    Patients

    Seq Age Sex Outcome Treatment
    1