BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-JKA

    MDR report key: 2527070 · Received June 16, 2009

    Report

    Report Number
    9610824-2009-00004
    Event Type
    Malfunction
    Date Received
    June 16, 2009
    Date of Event
    May 12, 2009
    Report Date
    June 10, 2009
    Manufacturer
    BIOTEST MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE RETENTION SAMPLES AND THE COMPLAINT SAMPLES OF CUSTOMERS REACTED CORRECTLY. THE TRANSPORT WAS PERFORMED COMPLYING WITH ALL LIMITATIONS. WE HAVE NO HINT THAT SOMETHING HAPPENED TO THE REAGENT. WE KNOW THAT TIME OF CENTRIFUGATION HAS TO BE KEPT AND THAT THE RESUSPENDING OF THE RED CELLS AFTER CENTRIFUGATION HAS TO BE DONE VERY CAREFULLY. THEREFORE WE ASSUME A PROBLEM OF HANDLING AT CUSTOMER'S SIDE. OUR TESTS IN THE QUALITY CONTROL LABORATORIUM CONFIRM THE CORRECT FUNCTION OF THE REAGENT. CORRECTIVE ACTION: ALL US CUSTOMERS WILL BE RETRAINED TO COMPLY WITH THE TESTING PROCEDURE AS DOCUMENTED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    COMPLAINT TESTING (B)(4), FALSE NEGATIVE REACTIONS WITH BLOOD GROUPING REAGENT ANTI-JK(A) B)(4), LOT 7829170-01. THE RETENTION SAMPLE OF THE COMPLAINED LOT WAS TESTED IN THE QUALITY CONTROL LABORATORIUM ACCORDING TO THE INSTRUCTIONS FOR USE. THE TESTING WAS PERFORMED WITH 4 DIFFERENT EDTA PLASMA (B)(4) AND 3 DIFFERENT PATIENT SAMPLES (B)(6) OF CUSTOMERS OF THE COMPLAINTS (B)(4). IN ALL CASES THE JK(A) POSITIVE RED CELLS REACTED CORRECTLY AND STRONG POSITIVE. THE REACTION STRENGTH WERE 3+ POSITIVE AT MINIMUM. THE RED CALL JK(A-B+) AS NEGATIVE CONTROL REACTED UNAMBIGUOUSLY NEGATIVE. THE CUSTOMER OF THE COMPLAINT (B)(4) SENT US THREE PATIENT SAMPLES WHICH WERE COMPLETELY HEMOLYSED AND COULD THEREFORE NOT BE TESTED. WE RECEIVED TWO VIALS OF REAGENT OF THE CUSTOMER. ONE VIAL DIDN'T CONTAIN ENOUGH REAGENT FOR TESTING, THE OTHER VIAL WAS TESTED. THIS COMPLAINT SAMPLE OF THE CUSTOMER AND THE RETENTION SAMPLE OF OUR SUBSIDARY WERE TESTED IN PARALLEL TO OUR QC RETENTION SAMPLE. ALL REAGENTS WERE TESTED IN A TWOFOLD SERIAL DILUTION AND SHOWED COMPLETELY CONFORM RESULTS. THEREFORE WE CAN NOT CONFIRM THE COMPLAINTS. WE KNOW IT IS VERY IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE, ESP. THE SPECIFICATIONS OF CENTRIFUGATION: 60 S AT 1000 X G. IF THE TIME OF CENTRIFUGATION IS SHORTER THAN 60 SECONDS THERE MAY OCCUR ONLY WEAK OR EVEN FALSE NEGATIVE REACTIONS WITH JK(A) POSITIVE RED CELLS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED THAT THE LOT PASSED THE FINAL SEROLOGICAL CONTROL PROBLEM-FREE. DURING THE STABILITY TESTING THERE WERE PERFORMED TRANSPORT SIMULATION DATA FOR THIS PRODUCT. THE EXISTING DATA OF TRANSPORTATION PROOF THE KEEPING OF THE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-JKA SERACLONE KSZ BIOTEST MEDICAL DIAGNOSTICS GMBH 7829170-01

    Patients

    Seq Age Sex Outcome Treatment
    1