BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURG 3X10ML

    MDR report key: 24910283 · Received April 17, 2026

    Report

    Report Number
    2250051-2026-00017
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    QHT
    UDI-DI
    10758750007660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS: THE CUSTOMER STATED THAT QUALITY CONTROL (QC) PASSED ON THE DAY OF USE. CONFIRMATION WAS NOT PROVIDED. THE CARD AND REAGENT RED BLOOD CELLS STORAGE AND USAGE CONDITIONS WERE CHECKED AND CONFIRMED TO BE ALIGNED WITH ORTHO'S RECOMMENDATIONS. THE CUSTOMER REPORTED VISUAL APPEARANCE WAS ACCEPTABLE FOR THE GEL CARDS AND REAGENT RED BLOOD CELLS AT THE TIME OF USE. ON 30MAR2026, GTSC OBTAINED THE ORDER REPORTS FROM THE CUSTOMER IN ADDITION TO THE COLUMN GRADE RESULTS LOG AND RESULT IMAGES FROM THE VISION ANALYZER VIA E-CONNECTIVITY (ECONN). THE REVIEW OF THE ORDER REPORTS AND ANALYZER DATA INDICATE THE CUSTOMER OBTAINED RESULTS FOR ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION AS FOLLOWS: SAMPLE 1, TESTED ON (B)(6) 2026: - ANTIBODY SCREEN CELLS 1 AND 3: NEGATIVE CELL 2: INDETERMINATE (IND, "?"), MANUALLY REVIEWED AND CHANGED TO NEGATIVE - RETEST OF SAME SAMPLE YIELDED THE SAME NEGATIVE RESULTS SAMPLE 1, TESTED ON (B)(6) 2026: - ANTIBODY SCREEN CELLS 1, 2 AND 3: NEGATIVE - ANTIBODY ID CELLS 1, 4 AND 9: 1+ REACTION CELL 11: IND ALL OTHER CELLS: NEGATIVE SAMPLE 2, COLLECTED AND TESTED ON (B)(6) 2026: - ANTIBODY SCREEN CELLS 1, 2 AND 3: NEGATIVE - ANTIBODY ID CELLS 4 AND 9: 1+ REACTION CELL 11: IND ALL OTHER CELLS: NEGATIVE ACCORDING TO ORTHO LOT-SPECIFIC INFORMATION FOR 0.8% SURGISCREEN LOT: VSS728, CELL 1 IS POSITIVE AND HETEROZYGOUS, CELL 2 IS POSITIVE AND HOMOZYGOUS, AND CELL 3 IS NEGATIVE FOR THE JKA (JK1) ANTIGEN. THEREFORE, IT FOLLOWS THAT THE NEGATIVE REACTIONS WITH CELLS 1 AND 2 OBTAINED WITH THE PATIENT SAMPLE ARE NOT CONSISTENT WITH THE EXPECTED REACTIVITY OF AN ANTI-JKA (JK1) ANTIBODY. ACCORDING TO ORTHO LOT-SPECIFIC INFORMATION FOR 0.8% RESOLVE PANEL A LOT: VRA506, CELLS 1, 4 AND 9 ARE POSITIVE AND HOMOZYGOUS, CELLS 3, 5, 6 AND 11 ARE POSITIVE AND HETEROZYGOUS, AND THE REMAINING CELLS ARE NEGATIVE FOR JKA (JK1) ANTIGEN. THEREFORE, IT FOLLOWS THAT THE REACTIONS OBTAINED WITH SAMPLE 1 ARE CONSISTENT WITH A WEAK ANTI-JKA (JK1) ANTIBODY. THE NEGATIVE REACTION OBTAINED WITH SAMPLE 2 AND CELL 1 IS NOT CONSISTENT, ALTHOUGH POSSIBLE WITH A WEAK ANTI-JKA (JK1) ANTIBODY. A REVIEW OF MANUFACTURING BATCH RECORD OF 0.8% SURGISCREEN LOT: VSS728. NO NON-CONFORMANCE'S OR DEVIATIONS WERE IDENTIFIED. THE RESULTS OF ALL IN-PROCESS AND QUALITY ASSURANCE RELEASE TESTING WERE FOUND TO BE WITHIN SPECIFICATIONS, INCLUDING ANTIGEN SPECIFICITY TEST. LOT: VSS728 MET ALL ACCEPTANCE CRITERIA. A REVIEW OF MANUFACTURING BATCH RECORD OF MTS ANTI-IGG GEL CARD LOT: 110825001-06 WAS REQUESTED FROM ORTHO'S MANUFACTURING SITE. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. ALL IN-PROCESS AND FINAL RELEASE SEROLOGICAL TESTING RESULTS WERE WITHIN SPECIFICATIONS, INCLUDING CUSTOMER USE ORTHO VISION TESTING RESULTS. ALL QC INSPECTION RECORDS (PACKAGING AND GEL CARD INSPECTION DOCUMENTS) OF THIS PRODUCT LOT INDICATED ACCEPTABLE RESULTS; NO GEL CARD DEFECTS WERE IDENTIFIED DURING QC INSPECTION. ALL ID-MTS GEL CARDS USED DURING IN-PROCESS QC TESTING PASSED THE VISUAL CHECK PERFORMED BY THE SEROLOGIST. FORMULATION STAGE BATCH RECORD (ANTI-IGG LOT: 110825001) ASSOCIATED WITH THIS ID-MTS GEL CARD LOT WAS REVIEWED AND ONE NON-CONFORMANCE (NC) WAS INITIATED FOR INCORRECT CONVERSION FACTOR USED AT BOTTLE STAGE FOR TOTAL PROTEIN. THROUGH THE NC PROCESS, THE CONVERSION FACTOR WAS CORRECTED, AND RESULTS OF TOTAL PROTEIN MET ACCEPTANCE CRITERIA, THEREFORE PRODUCT WAS RELEASED TO FILL. THE EQUIPMENT AREA USE LOG USED DURING PRODUCTION OF THIS LOT WAS REVIEWED AND NO CONDITIONS OR ACTIONS TAKEN WERE FOUND TO DIRECTLY CONTRIBUTE TO THIS CUSTOMER COMPLAINT. THE LOT MET ALL SPECIFICATIONS, ALL IN-PROCESS AND PRODUCT RELEASE CRITERIA. TESTING OF RETAINED SAMPLES OF 0.8% SURGISCREEN LOT: VSS728 WAS REQUESTED AND PERFORMED BY ORTHO'S MANUFACTURING SITE. VISION MTS INDIRECT ANTIGLOBULIN TEST (IAT) WAS PERFORMED ON 0.8% SURGISCREEN LOT: VSS728, AS PER IFU, WITH MTS ANTI-IGG CARD LOT: 071025001-12 WITH KNOWN PLASMA ANTI-D, ANTI-K, ANTI-FYA. EXPECTED POSITIVE AND NEGATIVE RESULTS WERE OBTAINED. MTS ANTI-IGG CARD LOT: 110825001-06 WAS UNAVAILABLE. CELLS 1 AND 2 WERE TESTED IN TUBE FOR THE PRESENCE OF THE JKA ANTIGEN. FIRST THE 0.8% RETAIN CELLS WERE CONVERTED TO A 3% CELL SUSPENSION IN ORS, ORTHO RESUSPENSION SOLUTION, USING LOT#: RS889A, FOLLOWING PROCEDURES AND TESTED IN TUBE AS PER IFU FOR THE JKA ANTIGEN. AFTER A 5-MINUTE ROOM TEMPERATURE INCUBATION, EXPECTED POSITIVE REACTIONS WERE OBSERVED. RESULTS MEET SPECIFICATIONS WITH 3-3.5+ REACTION STRENGTH, A MINIMUM REACTION OF A 2+ REACTION IS REQUIRED. 0.8% SURGISCREEN LOT: VSS728 PERFORMED AS EXPECTED AND CONTINUES TO MEET RELEASE SPECIFICATIONS. ANTI-IGG CARD LOT#: 110825001-06 RETENTION CARDS WERE TESTED ON THE ORTHO VISION ANALYZER WITH 0.8% SURGISCREEN LOT#: VSS728 AND ORTHO DAILY QC KIT LOT#: EB031 CONTAINING ANTI-D, ANTI-FYA AND ANTI-C. SAMPLES CONTAINING ANTI-K AND ANTI-JKA WERE NOT AVAILABLE FOR TESTING. PRODUCT TESTING WITH RETAIN CARDS PERFORMED AS EXPECTED. NO DISCREPANT RESULTS OBTAINED WITH ORTHO DAILY QC KIT SAMPLES. A TOTAL OF 100 RETENTION CARDS OF ANTI-IGG CARD LOT#: 110825001-06 WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. ANTI-IGG CARD LOT#: 110825001-06 PERFORMED AS INTENDED AND THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE COMPLAINTS ASSOCIATED WITH THE RED CELL REAGENTS MANUFACTURED USING THE SAME DONORS AS THOSE USED TO MANUFACTURE JKA (JK1) ANTIGEN-POSITIVE CELLS OF 0.8% SURGISCREEN LOT: VSS728. NO SYSTEMATIC FAILURE OR TREND WITH THESE DONORS WAS IDENTIFIED. A REVIEW OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED FOR 0.8% SURGISCREEN LOT: VSS728 (EXPIRY: 14APR2026) THROUGH 08APR2026. NO ADDITIONAL COMPLAINT WAS IDENTIFIED FOR THE LOT RELATED TO FALSE NEGATIVE REACTIONS. NO TREND WAS IDENTIFIED. IN ADDITION, A COMPLAINT REVIEW OF THE MTS ANTI-IGG GEL CARD LOT: 110825001-06 AND MASTER BULK LOT: 110825001 WAS PERFORMED THROUGH 08APR2026. NO COMPLAINTS WERE IDENTIFIED RELATING TO FALSE NEGATIVE REACTIONS AGAINST LOT: 110825001-06. TWO COMPLAINTS AGAINST TWO ALTERNATE SUBLOTS WERE LOGGED AND INVESTIGATED UNDER ANOTHER RECORD, FOR FALSE NEGATIVE REACTIONS IN DIRECT ANTIGLOBULIN TEST (DAT) FOR ONE PATIENT SAMPLE. NO TRENDS WERE IDENTIFIED FOR THE SUBLOT OR MASTER BULK LOT. NO FURTHER INVESTIGATION WAS PERFORMED ON THIS INCIDENT. THE ASSIGNABLE CAUSE OF THE DISCORDANT ANTIBODY SCREEN REACTIONS OBTAINED BY THE CUSTOMER IS LIKELY SAMPLE RELATED, THE PATIENT'S ANTI-JKA (JK1) ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED AND/OR ASSOCIATED TO THE VARIABILITY OF THE JKA (JK1) ANTIGEN EXPRESSION ON THE REAGENT RED BLOOD CELLS. IN ANY CASE, THERE IS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO REAGENTS OR ANALYZERS TO PERFORM AS INTENDED. IN MITIGATION OF THE DISCORDANT NEGATIVE ANTIBODY SCREEN AND IDENTIFICATION RESULTS, THE 0.8% SURGISCREEN INSTRUCTIONS FOR USE (IFUS) STATE: FOR ANTIBODY DETECTION AND IDENTIFICATION, DIFFERENT SEROLOGICAL METHODS ARE OPTIMAL FOR DIFFERENT ANTIBODIES. NO SINGLE ANTIBODY SCREENING OR IDENTIFICATION METHOD OPTIMALLY DETECTS ALL ANTIBODIES. NO OTHER COMPLAINT OF THIS TYPE HAS BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENTS.

    Description of Event or Problem · 0

    REPORT 1 OF 2 (B)(4) / RA614154 ON 27MAR2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN FOR ONE PATIENT USING 0.8% SURGISCREEN LOT: VSS728 WITH ORTHO MTS ANTI-IGG GEL CARD LOT: 110825001-06 ON THEIR ORTHO VISION SWIFT ID-MTS (B)(6). COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST; (B)(6) CUSTOMER (B)(6) (B)(6) HOSPITAL (B)(6) USA DATE OF EVENT: 26MAR2026 AND 29MAR2026, REPORTED ON 27MAR2026 REAGENTS: 0.8% SURGISCREEN LOT: VSS728, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 MTS ANTI-IGG GEL CARD LOT: 110825001-06, EXPIRATION: 24AUG2026, MANUFACTURE: 24NOV2025 OTHER REAGENTS: 0.8% RESOLVE PANEL A LOT: VRA506, EXPIRATION: 14APR2026 INSTRUMENT: ORTHO VISION SWIFT ID-MTS S/N: (B)(6); SW VERSION 5.16.0 PATIENT INFORMATION: PATIENT HAS A HISTORY OF AN ANTI-JKA (JK1) ANTIBODY. SAMPLE 1 ID: (B)(6); ENCRYPTED ID- 80-FE-55-7D-8F-8B-E6-88-26-F1-EA-8C-6A-39-F9-8F-A9-A4-3F-67-F9-49-6D-BC-C8-0F-5D-4D-A6-B3-02-DD SAMPLE 2 ID: (B)(6); ENCRYPTED ID- 62-EF-E0-B7-F6-C9-A3-C2-62-0A-BF-09-50-10-3B-0B-E2-1C-58-00-43-44-27-76-11-BC-9D-C1-C2-DC-7B-8D THE CUSTOMER REPORTED THAT ON (B)(6) 2026, SAMPLE 1 FROM THE PATIENT WAS TESTED FOR ANTIBODY SCREEN USING 0.8% SURGISCREEN LOT: VSS728 WITH MTS ANTI-IGG GEL CARD LOT: 110825001-06 ON THE ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6) AND A NEGATIVE REACTION WAS OBTAINED WITH ALL THREE SCREENING CELLS. THE CUSTOMER REPORTED THAT SAMPLE 1 WAS RE-TESTED ON THE SAME DAY FOR ANTIBODY SCREEN WITH THE SAME REAGENTS ON THE SAME INSTRUMENT, AND THE NEGATIVE RESULTS PERSISTED. THE CUSTOMER STATED THAT SAMPLE 1 WAS SENT TO A SISTER FACILITY, WHERE IT WAS TESTED WITH 0.8% SURGISCREEN LOT: VSS723 (EXPIRY: 31MAR2026) AND RESULTED IN A POSITIVE ANTIBODY SCREEN, CELL 3 (HOMOZYGOUS FOR JKA (JK1) ANTIGEN) HAD A REACTION STRENGTH OF 2+ AS EXPECTED. AN ANTIBODY TITER WAS ALSO PERFORMED BY THE SISTER FACILITY AND RESULTED IN A 1:4 TITER RESULT. NO FURTHER DETAILS WERE PROVIDED. ON (B)(6) 2026, THE CUSTOMER REPORTED THAT SAMPLE 1 WAS RETESTED AGAIN WITH THE SAME REAGENTS AS THE ORIGINAL RUN, ON THE SAME INSTRUMENT, AND THE NEGATIVE ANTIBODY SCREEN REACTIONS PERSISTED. THE CUSTOMER STATED THAT A BIASED RESULT WAS INITIALLY REPORTED TO THE PHYSICIAN. NEW TEST ORDER RESULTED AS POSITIVE AT THE SISTER FACILITY. THE PATIENT WAS NOT HARMED AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972030 0.8% SURG 3X10ML REAGENT RED BLOOD CELLS QHT ORTHO-CLINICAL DIAGNOSTICS, INC. VSS728 10758750007660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown