BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K TYPE

    MDR report key: 2382000 · Received December 20, 2011

    Report

    Report Number
    9610824-2011-00199
    Event Type
    Malfunction
    Date Received
    December 20, 2011
    Date of Event
    November 29, 2011
    Report Date
    January 19, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS TESTED WITH ERYTYPE S RH+K TYPE AND REACTED POSITIVELY WITH BOTH ANTI-D REAGENTS. THIS VERY PATIENT WAS ALSO TESTED WITH ERYTYPE S ABD+REV.A1, B AND REACTED NEGATIVELY WITH BOTH ANTI-D REAGENTS. TWO SAMPLES OF THIS PATIENT THAT HAD CAUSED POSITIVE REACTIONS WERE SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. WE RECEIVED THE TWO SAMPLES OF THE SAME CUSTOMER WITH DIFFERENT BLOOD WITHDRAWAL DATES ((B)(6) 2011). THE SAMPLE WHICH WAS LABELED WITH (B)(6) 2011 SHOWED A STRONG HEMOLYSIS. OUR QUALITY CONTROL LABORATORY RE-TESTED THE TWO SAMPLES OF THE PATIENT WITH THE RETAINED SAMPLE OF ERYTYPE S RH+K TYPE. THE SAMPLE LABELED (B)(6) 2011 REACTED NEGATIVELY WHILE SAMPLE LABELED (B)(6) 2011 REACTED POSITIVELY. FURTHER TESTINGS OF THE SAMPLES WITH DIFFERENT ANTI-D REAGENTS YIELDED IN POSITIVE RESPECTIVELY NEGATIVE RESULTS. THEREFORE THE TWO SAMPLES WERE SENT FOR MOLECULAR RH(D) TYPING TO AN EXTERNAL LABORATORY. THE LABORATORY TYPED THE TWO SAMPLES AS WEAK D TYPE 42. IN THE INSTRUCTION FOR USE OF ERYTYPE S ABD+REV.A1, B THE CUSTOMER CAN FIND UNDER "LIMITATIONS" THAT ....."CATEGORY VII AND VERY WEAK EXPRESSIONS OF THE D ANTIGEN (D WEAK WITH VERY FEW RECEPTORS) WILL GIVE WEAKENED OR NEGATIVE REACTIONS WITH THE ANTI-D REAGENTS ON THIS STRIP." TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K TYPE FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. NO INDICATION FOR AN INSTRUMENT MALFUNCTION COULD BE DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT A DISCREPANT TEST RESULT ON THE TANGO WITH ERYTYPE S RH+K TYPE. A PATIENT SAMPLE RUN ON THE TANGO ABDREVAB PLATE AND THE RH GROUP WAS NEGATIVE IN BOTH D WELLS. WHEN RUN ON THE RH KELL PLATE, BOTH D WELLS SHOW 4+ REACTIONS. THE SAMPLE WAS REPEATED ON THE SECOND TANGO SYSTEM IN LAB AND SIMILAR RESULTS WERE OBTAINED. TUBE TESTING WAS ALSO PERFORMED USING SERACLONE ANTI-D BLEND (IGG/IGM). BOTH RESULTS FOR IMMEDIATE SPIN AND INCUBATION AT 30 DEGREES C WERE NEGATIVE. THE PATIENT WAS TYPED AS RH POSITIVE BACK IN 2009 (3+ IN TUBE). BABY DELIVERED ON (B)(6). BABY IS DAT NEGATIVE, NEGATIVE IN TUBE, DU 3+. BOTH ANTI-D CLONES ARE THE SAME FOR ABDREVAB AND RH KELL. THE CUSTOMER WAS ABLE TO SEND US A PATIENT SAMPLE BUT NONE OF THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K TYPE. OUR QUALITY CONTROL LABORATORY IS RE-TESTING, USING THE RETAINED MATERIAL OF THIS VERY LOT. TESTING IS STILL ONGOING. THE PATIENT SAMPLE WAS ALSO SENT TO AN EXTERNAL LAB FOR MOLECULAR TYPING. AS SOON AS WE'LL GET THE TEST RESULTS FROM BOTH LABS, WE WILL SEND IN OUR FINAL REPORT ON THIS INCIDENT. NO INDICATION FOR AN INSTRUMENT MALFUNCTION COULD BE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERYTYPE S RH+K TYPE ERYTYPE S RH+K TYPE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7048030

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO, SERIAL NO. (B)(4)| SERACLONE ANTI-D BLEND, LOT 1032071, EXP. 08/01/12| ERYTYPE S ABD-REV A1,B, LOT 8115090, EXP. 10/07/12| SERACLONE ANTI-D BLEND, LOT 1032071, EXP. 08/01/12| ERYTYPE S ABD-REV A1,B, LOT 8115090, EXP. 10/07/12| TANGO OPTIMO, SERIAL NO. (B)(4)