BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

    MDR report key: 19971683 · Received August 13, 2024

    Report

    Report Number
    9610824-2024-00032
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 FALSE POSITIVE REACTIONS ON THE ANTI-B WELL OF 0 IH-CARD ABO/D(DVI-)+REV A1,B WHEN USED ON THE IH-1000. THE SAMPLE WAS FALSE POSITIVE 1+ ON ANTI-B WITH IH-CARD ABO/D(DVI-)+REV A1,B WHILE A REPEAT TESTING FOUR DAYS LATER ON THE SAME INSTRUMENT YIELDED AS NEGATIVE ON ANTI-B. THE CUSTOMER ANNOUNCED TO SEND IN THE PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. WHILE OUR QUALITY CONTROL LAB WAITED FOR THESE SAMPLES, THE STAFF TESTED THEIR RETENTION SAMPLES OF THE SUPPOSEDLY DEFECTIVE IH-CARD ABO/D(DVI-)+REV A1,B. THE LAB TESTED ALSO LOT 9346030 WHICH THE CUSTOMER HAD ALSO USED BUT WHICH HAD NOT RESULTED IN A FALSE POSITIVE RESULT. THE CARDS WERE VISUALLY INSPECTED AND SHOWED NO ABNORMALITIES. THERE WAS SUFFICIENT GEL IN ALL WELLS. INHOMOGENEITY OF THE GEL COLUMNS, AS WELL AS GEL SPLASHES IN THE REACTION CHAMBERS WERE NOT DETECTED. THE SEALING OF THE CARDS WERE FLAWLESS. IN ADDITION, 3 CARDS WERE OPENED FROM EACH BATCH OF CARDS. THERE WASN`T ANY ANTISERUM ON THE BOTTOM OF THE FOIL. TO CHECK THE SPECIFICITY OF THE COMPLAINED CARD BATCH ON THE IH-1000, 14 DIFFERENT EDTA DONOR BLOOD ( 6 X A RHD POS, 5 X O RHD POS, 1 X O RHD NEG, 1 X B RHD POS, 1 X B RHD NEG ) WITH KNOWN BLOOD GROUPS WERE TESTED, WITH FOCUS ON DONORS OF THE BG A RH D POS. OR O RH D POS. LOT 9346030 WAS TESTED IN PARALLEL. ALL DONOR RBCS REACTED CORRECTLY POSITIVE OR NEGATIVE ACCORDING TO THE BLOOD GROUP. FALSE POSITIVE REACTIONS IN THE ANTI-B WELL COULD NOT BE CONFIRMED. THE PATIENT SAMPLES SENT BY THE CUSTOMER WERE TESTED WITH THE COMPLAINED CARD BATCH ON THE IH-1000. NO FALSE POSITIVE RESULT IN THE ANTI-B WELL WERE OBSERVED. THE INVESTIGATION OF THE TRACE FILES OF THE AFFECTED IH-INSTRUMENT IS STILL ONGOING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH TWO PATIENT SAMPLES ON THE ANTI-B WELL OF IH-CARD ABO/D(DVI-)+REV A1,B WHEN USED ON THE IH-1000. SAMPLES (B)(6) (TESTED ON (B)(6) 2024 ON IH-1000 S/N (B)(6)) WERE FALSE POSITIVE 1+ ON ANTI-B WITH IH-CARD ABO/D(DVI-)+REV A1,B, LOT 9341010. THE SAMPLES WERE REPEATED ON (B)(6) 2024 ON THE SAME INSTRUMENT BUT WITH IH-CARD ABO/D(DVI-)+REV A1,B LOT 9346030 AND REACTED NEGATIVE ON THE ANTI-B. AT FIRST OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CARD ABD/D(DVI-)+REV A1,B, LOT 9341010. THE VISUAL INSPECTION FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER WAS PASSED WITHOUT ANY IRREGULARITIES. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. WE ALSO REMOVED THE FOIL FROM SOME CARDS TO INVESTIGATE IF ANY SIGNS OF ANTISERA SPLASHES COULD BE VISIBLE, WHICH WAS NOT THE CASE. THE CUSTOMER PROVIDED THE TWO PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH 14 DIFFERENT DONOR SAMPLES (( 6 X A RHD POS, 5 X O RHD POS, 1 X O RHD NEG, 1 X B RHD POS, 1 X B RHD NEG ) AND WITH THE TWO PATIENT SAMPLES PROVIDED BY THE CUSTOMER ON THE IH-1000. AS THE REASON FOR THE COMPLAINT WAS FALSE POSITIVE REACTIONS IN THE ANTI-B, THE FOCUS WAS ON THE TESTING OF BLOOD GROUP A AND O RHD-POSITIVE BLOOD SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION IN THE ANTI-B WITH THE RETENTION SAMPLE. THE PATIENT SAMPLES SENT BY THE CUSTOMER SHOWED THE FOLLOWING RESULTS: SAMPLE (B)(6): O RHD POS. SAMPLE (B)(6): A RHD POS. THE FORWARD AND REVERSE TYPING MATCHED, THE FALSE POSITIVE REACTIONS IN THE ANTI-B WELL COULD NOT BE CONFIRMED. THE SEROLOGICAL TESTS WERE PERFORMED IN PARALLEL WITH IH-CARD ABD/D(DVI-)+REV A1,B, LOT 9346030. AGAIN NO FALSE POSITIVE RESULTS WERE OBSERVED. DATA FILES AND IMAGES OF THE AFFECTED IH-1000 INSTRUMENT WERE REVIEWED. BOTH SAMPLE (B)(6) WERE TESTED ON (B)(6) 2024. THEY WERE PIPETTED BY THE RIGHT PIPETTOR AND THE NEEDLE WAS WASHED BEFORE AND AFTER DISPENSING THE PLASMA FOR THE TESTS. THE RED BLOOD CELLS WERE PIPETED FROM WELL 4 TO WELL 1, (CTRL, ANTI-D, ANTI-B AND THEN ANTI-A). THERE WERE NO ERRORS DURING PROCESSING OTHER THAN THE ALARM OF THE SOLID WASTE BIN FULL (POUBELLE SOLIDE: THRESHOLD REACHED). BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). THE RETENTION SAMPLE REACTED AS EXPECTED, WITH BOTH PATIENT SAMPLES PROVIDED BY THE CUSTOMER AND BLOOD SAMPLES FROM OUR DONATION CENTER. ALL ACCEPTANCE CRITERIA REGARDING VISUAL INSPECTION AND SPECIFICITY WERE MET, WE DID NOT OBSERVE ANY FALSE POSITIVE RESULTS.HOWEVER, THE IMAGES PROVIDED AND THE TRACE FILES ANALYSIS CONFIRMED CUSTOMER´S REPORTED FALSE POSITIVE RESULTS. THE RESULTS SEEM TO BE RELATED TO A CARRYOVER FROM THE ANTI SERA OF WELL 3 (ANTI-D) TO WELL 2 (ANTI-B) CAUSING THE FALSE POSITIVE ON WELL ANTI-B. HOWEVER, WE DO NOT HAVE ANY IMAGES OF THE CARD BEFORE PROCESSING. AS A ROOT CAUSE ISSUES DURING THE TRANSPORTATION OR HANDLING OF THE IH-CARDS ARE SUSPECTED. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING, AND DUE TO THE 1+ RESULT INTERPRETATION, WHICH IS CONSIDERED AS "NOT INTERPRETABLE" ACCORDING TO THE IFU, NO FALSE BLOOD GROUP TYPING OCCOURED AT THE CUSTOMER SITE. WE HIGHLY RECOMMENDED TO THE CUSTOMER NOTING THE FOLLOWING POINTS ACCORDING TO THE CHAPTER PRECAUTIONS OF THE INSTRUCTION FOR USE: · DO NOT USE CARDS SHOWING SIGNS OF DRYING, DISCOLORATION, BUBBLES, CRYSTALS OR OTHER ARTIFACTS. · DO NOT USE CARDS WITH DAMAGED FOIL STRIPS. · DO NOT USE GEL CARDS IF THE GEL MATRIX IS ABSENT OR IF THE LIQUID LEVEL IN THE MICROTUBE IS NOT AT OR BELOW THE GEL MATRIX. A CLEAR LIQUID LAYER SHOULD BE VISIBLE ON TOP OF THE UNIFORM GEL MATRIX IN EACH MICROTUBE. · CARDS WITH DISPERSED DROPS OBSERVED AT THE TOP OF THE MICROTUBE, DUE TO IMPROPER STORAGE OR SHIPPING CONDITIONS, HAVE TO BE CENTRIFUGED WITH IH-CENTRIFUGE L OR IH-READER 24 WITH PRESET TIME AND SPEED BEFORE USE. IF DROPS ARE STILL OBSERVED ON TOP OF THE MICROTUBE AFTER ONE CENTRIFUGATION IT IS RECOMMENDED TO NOT USE THE CARD." AT THIS POINT IN TIME WE DID NOT RECEIVE ANY FURTHER COMPLAINTS FROM DIFFERENT CUSTOMERS REGARDING IH-CARD ABO/D(DVI-)+REV. A1, B LOT: 9341010. 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
    1895517 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 9341010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IH-1000, SN 5100056| IH-1000, SN 5100056| IH-CARD ABO/D(DVI-)+REV A1,B, LOT 9346030| IH-CARD ABO/D(DVI-)+REV A1,B, LOT 9346030