BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-PANEL 11

    MDR report key: 18948863 · Received March 21, 2024

    Report

    Report Number
    9610824-2024-00005
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 24, 2024
    Report Date
    May 16, 2024
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952298
    PMA / PMN Number
    125208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 FALSE POSITIVE REACTION OF CELL NO. 8 (DONOR NO. 103493) OF IH-PANEL 11 WITH ANTI-N. ACCORDING TO THE ANTIGEN TABLE CELL NO. 8 WAS N ANTIGEN NEGATIVE, BUT MMSS. THE CUSTOMER STATED THAT THEY RECEIVED A POSITIVE REACTION WITH CELL NO.8 OF IH-PANEL 11 AND SERACLONE ANTI-N. THE CUSTOMER INTENDS TO RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESING BUT HASN'T DONE SO YET.. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. CELL NO.8 OF IH-PANEL 11 WAS TESTED WITH SERACLONE ANTI-M AND SERACLONE ANTI-N ACCORDING TO THE INSTRUCTION FOR USE (TUBE TEST, INCUBATION FOR 30 MINUTES AT ROOM TEMPERATURE, READING OF THE RESULTS; NO CENTRIFUGATION). CELL NO.8 OF IH-PANEL 11 SHOWED A CORRECTLY NEGATIVE RESULT WITH SERACLONE ANTI-N, WHILE THE REACTION WITH SERACLONE ANTI-M WAS CORRECTLY POSITIVE. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED A CORRECT RESULT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. BASED ON THE CURRENT TESTS OF OUR QUALITY CONTROL LABORATORY, A MISTYPING OF CELL NO. 8 OF IH-PANELL 11 (DONOR NO. 103493) CAN BE EXCLUDED. THE DONOR 103493 HAS ALREADY BEEN IN USE FOR THE PANED REAGENT RED BLOOD CELLS FOR FOUR YEARS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF CELL NO. 8 (DONOR NO. (B)(6)) OF IH-PANEL 11 WITH ANTI-N. ACCORDING TO THE ANTIGEN TABLE CELL NO. 8 WAS N ANTIGEN NEGATIVE, BUT MMSS. THE CUSTOMER STATED THAT THEY RECEIVED A POSITIVE REACTION WITH CELL NO.8 OF IH-PANEL 11 AND SERACLONE ANTI-N. FIRST, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. CELL NO.8 OF IH-PANEL 11 WAS TESTED WITH SERACLONE ANTI-M AND SERACLONE ANTI-N ACCORDING TO THE INSTRUCTION FOR USE (TUBE TEST, INCUBATION FOR 30 MINUTES AT ROOM TEMPERATURE, READING OF THE RESULTS; NO CENTRIFUGATION). CELL NO.8 OF IH-PANEL 11 SHOWED A CORRECTLY NEGATIVE RESULT WITH SERACLONE ANTI-N, WHILE THE REACTION WITH SERACLONE ANTI-M WAS CORRECTLY POSITIVE. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED A CORRECT RESULT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER SENT IN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING. WHEN WE RECEIVED THE MATERIAL RETURNED BY THE CUSTOMER, TESTIN AT OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE CUSTOMER VIAL OF IH-CELL NO. 8 REACTED CORRECTLY NEGATIVE WITH SERACLONE ANTI-N. THIS WAS ALSO CONFIRMED WITH OTHER M+N- RED CELLS. BUT WHEN THE IH-CELL NO. 8 WAS USED WITH IH-LISS AND SERACLONE ANTI-N IN THE TUBE TEST AS THE CUSTOMER DID, A FALSE POSITIVE REACTION OCCURRED. HOWEVER, THIS USE WAS NOT IN ACCORDANCE WITH THE IFU, BECAUSE IH-PANEL 11 AND IH-LISS ARE FOR USE IN THE IH SYSTEM, WHILE THE INTENDED USE OF SERACLONE ANTI-N IS THE TUBE TEST. A FALSE POSITIVE RESULT ONLY OCCURRED IN THIS USE AGAINST THE IFU. OTHERWISE, CELL NO. 8 OF IH-PANEL 11 (DONOR NO. (B)(6)) SHOWED CORRECT RESULTS. IN ADDITION, THE POTENCY AND SPECIFICITY OF THE CUSTOMER'S SERACLONE ANTI-N WAS TESTED AND CONFIRMED IN COMPARISON TO THE RETENTION SAMPLE. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNJUSTIFIED. BOTH THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE REACTED AS EXPECTED. CONTRARY TO THE IFU, THE CUSTOMER HAD PREPARED THE IH CELLS WITH IH-LISS (ALSO FOR THE IH SYSTEM AND NOT THE TUBE METHOD) FOR USE IN THE TUBE METHOD AND THE USE OF SERACLONE ANTI-N AND OBTAINED FALSE POSITIVE RESULTS. A FALSE POSITIVE RESULT ONLY OCCURRED IN THIS USE NOT ACCORDING TO THE IFU. THE COMBINATION OF RED BLOOD CELLS SUSPENDED IN IH-LISS AND SERACLONE ANTI-N WHICH DID NOT COMPLY WITH THE IFU LED TO THE FALSE POSITIVE REACTIONS. OTHERWISE, CELL NO. 8 OF IH-PANEL 11 (DONOR NO. (B)(6)) SHOWED CORRECT RESULTS. AN INCORRECT DETERMINATION OF THE CELL NO. 8 OF IH-PANEL 11 (DONOR NO. (B)(6)) REGARDING THE MNS SYSTEM CAN SAFELY BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532689 REAGENT RED BLOOD CELLS IH-PANEL 11 IH-PANEL 11; 11X4 ML KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 9406011 07611969952298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown