BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE RH+K 8-DOUBLE

    MDR report key: 11782322 · Received May 6, 2021

    Report

    Report Number
    9610824-2021-00029
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969950980
    PMA / PMN Number
    125205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE REACTIONS WITH ANTI-C OF ERYTYPE RH+K 8 DOUBLE WERE TOO WEAK POSITIVE RESPECTIVELY FALSE NEGATIVE. THE CUSTOMER STATED THAT BOTH ANTI-C CLONES (CLONE MS33 AND CLONE MS35) WERE AFFECTED. ADDITIONALLY, THE CUSTOMER INFORMED US THAT BOTH ANTI-K CLONES (CLONE MS56 AND CLONE 601) WERE ALSO AFFECTED: THE POSITIVE REACTIONS WERE TOO WEAK RESPECTIVELY FALSE NEGATIVE. THE CUSTOMER STATED THAT THE PROBLEM WAS OBSERVED DURING SEVERAL DAYS AND UP TO 50% OF THE ERYTYPE PLATES WERE AFFECTED. THE DATE WHEN THE WEAK POSITIVE RESPECTIVELY FALSE NEGATIVE REACTIONS HAPPENED COULD NOT BE SPECIFIED BY THE CUSTOMER SO WE REFRAIN FROM SENDING SEVERAL IDENTICAL REPORTS WITHOUT DATE OF EVENT BUT WILL SEND ONLY THIS REPORT. OUR QUALITY CONTROL LABORATORY STARTED TESTING OF THEIR RETENTION SAMPLE OF ERYTYPE RH+K 8 DOUBLE ON MAY 17TH, 2021: THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WAS TESTED AGAINST A REFERENCE LOT (#2046010) BY USING "BROMELIN ERYTYPE READY FOR USE", LOT 3051100-00 (2021-06-13). 10 CC, 2 CC, 4 CC AND 4 KK SAMPLES WERE TESTED. ALL REACTIONS WERE CLEARLY POSITIVE FOR ANTI-C 4+ AND FOR ANTI-K 4-4W+, RESPECTIVELY NEGATIVE FOR CC, KK. WHEN THE PRODUCT SAMPLES PROVIDED BY THE CUSTOMER FOR INVESTIGATIONAL TESTING ARRIVED ON OUR PREMISES, THEY WERE TESTED AGAINST THE RETENTION SAMPLES OF LOT #2007090. THE "BROMELIN ERYTYPE READY FOR USE", LOT 3051100-00 (2021-06-13), THAT WAS ALSO PROVIDED BY THE CUSTOMER WAS USED FOR TESTING AND ADDITIONALLY ANOTHER BROMELIN LOT #3113150-00 (2021-09-22). DURING THE TESTING IN OUR QUALITY CONTROL LABORATORY WE MAINLY USED HETEROZYGOUS RED BLOOD CELLS WITH THE ANTIGENS CC AND KK. ALL POSITIVE REACTIONS WERE CLEARLY POSITIVE. THE REACTION STRENGTH FOR THE POSITIVE REACTIONS WITH BOTH ANTI-C REAGENTS WAS 3+ TO 4+POSITIVE, WHILE THE POSITIVE REACTIONS WITH THE ANTI-K REAGENTS WERE 2+ TO 3+ POSITIVE. ADDITIONALLY, THE NEGATIVE SPECIFICITY WAS ALSO TESTED AND CONFIRMED. IN TOTAL OUR QUALITY CONTROL LABORATORY TESTED ALL 10 ERYTYPE RH+K 8-DOUBLE PLATES RETURNED BY THE CUSTOMER. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY WEAKENED RESPECTIVELY FALSE NEGATIVE RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY OF THE COMPLAINT SAMPLE AS WELL AS THE RETENTION SAMPLE CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE RH+K 8-DOUBLE FUNCTIONS CORRECTLY. THIS WAS CONFIRMED BY USING TWO DIFFERENT LOTS OF "BROMELIN ERYTYPE READY FOR USE" (#3051100-00, #3113150-00). BECAUSE IT WAS NOT POSSIBLE TO RETEST THE "BROMELIN FOR ERYTYPE READY FOR USE", THAT WAS USED BY CUSTOMER WHEN THE EVENT OCCURRED, THE COMPLAINT WAS CLASSIFIED AS UNDETERMINED. THE ROOT CAUSE OF THE WEAKENED RESPECTIVELY FALSE NEGATIVE REACTIONS COULD NOT BE IDENTIFIED. THE CUSTOMER STATED THAT THEY DID NOT CHANGE ANYTHING WITHIN THE TEST PERFORMANCE OF ERYTYPE. FURTHERMORE, THE CUSTOMER INFORMED US THAT THE ISSUE DID NOT REOCCUR WITH THE REPLACEMENT LOT OF ERYTYPE RH+K 8-DOUBLE. HOWEVER, THE ERYTYPE PLATES RETURNED BY CUSTOMER MET ALL ACCEPTANCE CRITERIA WHEN TESTED BY OUR QUALITY CONTROL LABORATORY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT REACTIONS WITH ANTI-C OF ERYTYPE RH+K 8 DOUBLE WERE TOO WEAK POSITIVE RESPECTIVELY FALSE NEGATIVE. THE CUSTOMER STATED THAT BOT ANTI-C CLONES (CLONE MS33 AND CLONE MS35 ) WERE AFFECTED. ADDITIONALLY, THE CUSTOMER INFORMED US THAT BOTH ANTI-K CLONES (CLONE MS56 AND CLONE 601) WERE ALSO AFFECTED. SHE CLAIMED THAT: THE POSITIVE REACTIONS WERE TOO WEAK RESPECTIVELY FALSE NEGATIVE. THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. THE CUSTOMER HAS NOT YET SENT IN THE ALLEGEDLY DEFECTIVE PRODUCT ERYTYPE RH+K 8-DOUBLE FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY STARTED TESTING THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE INVESTIGATION IS STILL ONGOING. 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
    680811 ERYTYPE RH+K 8-DOUBLE ERYTYPE RH+K 8-DOUBLE QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 2007090 07611969950980

    Patients

    Seq Age Sex Outcome Treatment
    1 BROMELIN ERYTYPE READY FOR USE, LOT 3051100-00.| BROMELIN ERYTYPE READY FOR USE, LOT 3103220-00.