BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11812424 · Received May 12, 2021

    Report

    Report Number
    9610824-2021-00030
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 23, 2021
    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
    OH, US
    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 QUESTION MARK RESULTS WITH IH-CARD ABO/D(DVI-)+REV. A1,B ON THE H-500. THE CUSTOMER STATED THAT THE REACTIONS WERE VISUALLY EVALUATED CLEARLY NEGATIVE. WITHIN THE REVIEW OF THE DAILY JOURNALS PROVIDED BY THE CUSTOMER SEVERAL ISSUES WERE OBSERVED: QUESTION MARK RESULTS INSTEAD OF NEGATIVE RESULTS. THE ISSUE CUSTOMER HAD COMPLAINED ABOUT. THE QUESTION MARKS OCCURRED IN THE ANTI-B AND CONTROL WELL. DOUBLE POPULATION RESULTS THAT WERE GRADED CORRECTLY AS SOME CELLS WERE AT THE BOTTOM OF THE WELL. A FALSE POSITIVE REACTION IN BLOOD GROUPING ON (B)(6) 2021: A PATIENT SUPPOSED TO BE O POSITIVE REACTED POSITIVE WITH ANTI-A AND ANTI-B. HOWEVER, AS THE CONTROL WELL ALSO SHOWED A POSITIVE REACTION THE RESULTS OF THIS CARD CANNOT BE INTERPRETATED. A FALSE NEGATIVE REACTION IN REVERSE TYPING ON (B)(6) 2021. THE NEGATIVE RESULT WITH THE B CELL WAS MODIFIED TO POSITIVE BY THE USER. THE IFU CONTAINS THE FOLLOWING LIMITATION: "DECREASED OR MISSING ABO ANTIBODY REACTIVITY MAY BE SEEN IN DISEASE STATES, THE ELDERLY OR INFANTS RESULTING IN FALSE NEGATIVE REACTIONS.". THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE (IH-CARD ABO/D(DVI-)+REV.A1, B, REF #813 112 100, LOT #8035010) NOR THE PATIENT SAMPLES THAT CAUSED THE INCORRECT RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH SEVERAL RANDOM DONOR SAMPLES ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE VISUALLY CORRECT AND CORRECTLY EVALUATED BY THE INSTRUMENT AS WELL. WE DID NOT SEE ANY OF THE ISSUES THAT OCCURRED AT CUSTOMER SITE. THE CUSTOMER DID PROVIDE DAILY JOURNALS AND DATA FILES FOR INVESTIGATION. BASED ON THE IMAGE IH-CARD ANALYSES, THE "?" INTERPRETATIONS WERE DUE TO HEMOLYSIS OR DUST. THEY ARE CONFIRMED AND JUSTIFIED. ADDITIONALLY, SOME "?". INTERPRETATIONS WERE DUE UNCENTERED WELLS WHICH LEAD TO THAT PARTS OF THE WALLS WERE INCLUDED IN THE WELL INTERPRETATION BY THE SOFTWARE. AS AN UPDATE OF THE SOFTWARE VERSION APPLIED ON THE IH-500 HAS ALREADY BEEN SCHEDULED, THESE REACTIONS WERE ALSO ANALYZED WITH THE UPCOMING VERSION AND IS WAS CONFIRMED THAT IN CASE OF UNCENTERED WELLS THE WELLS WERE INTERPRETED AS NEGATIVE. THE TESTING OF OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE PRODUCT OF IH-CARD ABO/D(DVI-)+REV.A1, B, REF #(B)(4), LOT #8035010 FUNCTIONS CORRECTLY AS NO FALSE POSITIVE REACTION OR QUESTION MARKS WERE OBSERVED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BASED ON THE IMAGES AS WELL AS THE TRACE FILE ANALYSIS OF THE QUESTIONABLE RESULTS THE COMPLAINT IS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). SOME QUESTIONABLE RESULT INTERPRETATIONS WERE JUSTIFIED DUE TO A SAMPLE RELATED HEMOLYSIS OR DUST ON THE IH-CARD. THEREFORE, WE WOULD LIKE TO RECOMMEND CHECKING THE STORAGE CONDITIONS OF THE CARDS AT CUSTOMER´S SITE. WE WOULD ALSO LIKE TO REFER TO THE CHAPTER STORAGE REQUIREMENTS OF THE INSTRUCTION FOR USE: "DO NOT STORE NEAR ANY HEAT, AIR CONDITIONING SOURCES OR VENTILATION OUTLETS.". HOWEVER, IN SOME CASES THE QUESTIONABLE RESULTS WERE DUE TO UNCENTERED WELLS.AS A RESULT, PARTS OF THE WALL OF THE WELL WERE INCLUDED IN THE WELL INTERPRETATION BY THE SOFTWARE. TO FIX THE QUESTIONABLE RESULT INTERPRETATION BECAUSE OF UNCENTERED WELLS, ACTIONS HAVE ALREADY BEEN TAKEN AND WILL BE IMPLEMENTED IN FORM OF A SOFTWARE UPDATE ON THE MARKET AS SOON AS POSSIBLE.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED QUESTION MARK RESULTS WHEN USING IH-CARD ABO/D(DVI-)+REV. A1, B ON IH-500. THE CUSTOMER STATED THAT THE REACTIONS WERE VISUALLY EVALUATED CLEARLY NEGATIVE. WITHIN THE REVIEW OF THE DAILY JOURNALS PROVIDED BY THE CUSTOMER SEVERAL ISSUES WERE OBSERVED: QUESTION MARK RESULTS INSTEAD OF NEGATIVE RESULTS. THE ISSUE CUSTOMER HAD COMPLAINED ABOUT: DOUBLE POPULATION RESULTS; A FALSE POSITIVE REACTION IN BLOOD GROUPING ON (B)(6) 2021; AND A FALSE NEGATIVE REACTION IN REVERSE TYPING ON (B)(6) 2021, THE NEGATIVE RESULT WITH THE A1 CELL WAS MODIFIED TO POSITIVE BY THE USER. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE OF IH-CARD ABO/D(DVI-)+REV.A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE INCORRECT RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT AND CORRECTLY EVALUATED BY THE INSTRUMENT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. A REVIEW OF THE DAILY JOURNALS AND THE DATA FILES OF THE AFFECTED IH-500 IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709222 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 8035010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-500, SN (B)(6).| IH-500, SN (B)(6).