BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-JK(A)

    MDR report key: 10217263 · Received July 1, 2020

    Report

    Report Number
    9610824-2020-00042
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969951741
    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 A CAP SURVEY SAMPLE WITH SERACLONE ANTI-JKA (LOT 8834250-01, REFER TO REPORT 9610824-2020-00041). THE CUSTOMER REPEATED TESTING OF THE CAP SURVEY SAMPLE USING SERACLONE ANTI-JKA LOT 8002200-01 AND THE RE-TEST WAS ALSO NEGATIVE. THE CUSTOMER STATED THAT THE POSITIVE CONTROL FOR THE SERACLONE ANTI-JKA WAS PERFORMED USING A HOMOZYGOUS CELL #1 OF BIOTESTCELL 1&2. THE JKA POSITIVE CONTROL WAS NEGATIVE BUT WHEN USING A READER, THE RESULT APPEARED TO BE +/-. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT (COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING), THE CAP SURVEY SAMPLE LABELED AS RB CAT-02 AND BIOTESTCELL 1&2 SHE HAD USED AS A CONTROL. OUR QUALITY CONTROL LABORATORY TESTED THE CAP SURVEY SAMPLE WITH THE COMPLAINT SAMPLE AND YIELDED A STRONG POSITIVE RESULT. ACCORDING TO THE INSTRUCTION FOR USE THE TEST WAS PERFORMED IN THE TUBE TECHNIQUE WITH AN INCUBATION FOR 15 MINUTES AT ROOM TEMPERATURE FOLLOWING A CENTRIFUGATION FOR 60 SECONDS AT 800 TO 1000 X G. THEN THE RED CELL BUTTONS WERE GENTLY DISLODGED AND MACROSCOPICALLY OBSERVED FOR AGGLUTINATION. CELL #1 OF BIOTESTCELL 1&2 PROVIDED BY THE CUSTOMER ALSO YIELDED A STRONG POSITIVE REACTION WITH THE COMPLAINT SAMPLE IN THE METHOD DESCRIBED IN THE INSTRUCTION FOR USE. ADDITIONALLY THE COMPLAINT SAMPLE WAS TESTED FOR POTENCY AND SPECIFICITY. THE MINIMUM TITER OF 8 WAS EXCEEDED. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-JKA FUNCTIONS CORRECTLY. 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
    680339 BLOOD GROUPING REAGENT ANTI-JK(A) SERACLONE ANTI-JK(A) QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8002200-01 07611969951741

    Patients

    Seq Age Sex Outcome Treatment
    1