MTS ANTI-IGG CARD 5X20

Report

Report Number: 1056600-2025-00016
Event Type: Malfunction
Date Received: November 19, 2025
Date of Event: October 30, 2025
Report Date: November 14, 2025
Manufacturer: MICROTYPING SYSTEMS
Product Code: QHS
UDI-DI: 10758750005994
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 STATES QUALITY CONTROL TESTING WAS PERFORMED ON THE DAY OF TESTING AND WAS ACCEPTABLE. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER STATES THE PRODUCTS WERE STORED AS PER ORTHO SPECIFICATIONS AND VISUAL INSPECTION PRIOR TO USE WAS ACCEPTABLE. THE CUSTOMER STATED THEY USED SEPARATE CELL SUSPENSIONS FOR WEAK D TEST AND DAT TEST. WEAK D SUSPENSION WAS PREPARED USING SALINE, AND DAT SUSPENSION WAS PREPARED USING DILUENT 2 PLUS. THE GTSC CONFIRMED THE CORRECT PROTOCOL FOR INCUBATION AND CENTRIFUGATION WERE USED FOR TESTING; CUSTOMER STATES INCUBATION AND CENTRIFUGATION FOLLOWED THE INSTRUCTIONS FOR USE (IFU). THE GTSC ALSO OBTAINED ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE PATIENT SAMPLE TESTING: - NO ELUTION WAS PERFORMED FOR ANTIBODY IDENTIFICATION. THE CUSTOMER STATED AN ELUTION IS ONLY PERFORMED IF THE PATIENT HAS BEEN RECENTLY TRANSFUSED; IN THIS CASE THE PATIENT WAS NOT RECENTLY TRANSFUSED. - ANTIBODY SCREEN PERFORMED ON THE PATIENT WAS NEGATIVE. THE GTSC REVIEWED THE IFU FOR THE MTS ANTI-IGG GEL CARD WITH THE CUSTOMER. UNDER THE TEST PROCEDURE FOR DIRECT ANTIGLOBULIN TEST IT STATES: "BRING SAMPLES AND REAGENTS TO ROOM TEMPERATURE (18-25C)". THE CUSTOMER ACKNOWLEDGED THE INFORMATION AND WILL ENSURE REAGENTS ARE AT ROOM TEMPERATURE PRIOR TO TESTING GOING FORWARD. ORTHO SECOND LEVEL WAS CONSULTED REGARDING TESTING FOR DAT USING PRE-WARMED GEL CARDS. IT WAS ADVISED THAT FOR DAT, AN INCUBATION STEP IS NOT PART OF THE TEST PROCEDURE AS PER IFU AND THE ADDITION OF THIS STEP WOULD BE CONSIDERED OFF-LABEL USE, AS THE TEST DETECTS ANTIGEN-ANTIBODY COMPLEXES WITH IGG THAT HAVE OCCURRED IN-VIVO. A REVIEW OF THE MANUFACTURING BATCH RECORD FOR MTS ANTI-IGG LOT 052025001-10 WAS CARRIED OUT AT THE ORTHO MANUFACTURING SITE 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 052025001) ASSOCIATED WITH THIS ID-MTS GEL CARD LOT WAS REVIEWED AND NO DISCREPANCIES WERE DISCOVERED. 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. THERE WERE NO PRODUCT NONCONFORMANCES RELATED TO THIS LOT. THE LOT MET ALL SPECIFICATIONS, ALL IN-PROCESS AND PRODUCT RELEASE CRITERIA. AS PART OF THE INVESTIGATION, RETAIN TESTING WAS REQUESTED AT THE ORTHO MANUFACTURING SITE. MTS ANTI-IGG GEL CARD LOT 052025001-10 PERFORMED AS INTENDED, WITH POSITIVE AND NEGATIVE REACTIONS AS EXPECTED. RETENTION CARDS WERE VISUALLY INSPECTED, AND NO DEFECTS WERE FOUND. THE INVESTIGATION DID NOT CONFIRM THE CUSTOMER COMPLAINT. A QUERY OF THE WORLDWIDE COMPLAINT DATABASES WAS PERFORMED FOR MTS ANTI-IGG GEL CARD LOT 052025001 THROUGH 12NOV2025. A TOTAL OF ONE COMPLAINT WAS IDENTIFIED FOR THE LOT RELATED TO FALSE NEGATIVE RESULTS. (THE CURRENT COMPLAINT UNDER INVESTIGATION.) FOR THOROUGHNESS, A REVIEW OF THE MOTHER BULK LOT 052025001 WAS ALSO PERFORMED FOR THE TIME-PERIOD. NO ADDITIONAL COMPLAINTS OF FALSE NEGATIVE RESULTS WERE OBSERVED FOR ANY ADDITIONAL SUBLOTS. NO TREND WAS IDENTIFIED BY SUBLOT OR MOTHER BULK LOT FOR FALSE NEGATIVE RESULTS. IN MITIGATION OF THE COMPLAINT, THE CUSTOMER WAS REFERRED TO THE INSTRUCTIONS FOR USE FOR MTS ANTI-IGG WHICH STATES UNDER DIRECT ANTIGLOBULIN TEST TO BRING SAMPLES AND REAGENTS TO ROOM TEMPERATURE PRIOR TO TESTING. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, ALTHOUGH USER ERROR COULD NOT BE EXCLUDED DUE TO THE CUSTOMER FAILING TO FOLLOW MANUFACTURER'S INSTRUCTIONS FOR REAGENT PREPARATION PRIOR TO TESTING. THERE WAS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO CLINICAL DIAGNOSTICS REAGENT AND ANALYZER TO PERFORM AS INTENDED. NO FURTHER COMPLAINTS OF THIS TYPE HAVE BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENT.

Description of Event or Problem · 0

(B)(4) / RA612664 ON 30OCT2025, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THEY TESTED ONE PATIENT SAMPLE FOR DAT USING MTS ANTI-IGG GEL CARD LOT 052025001-10 IN CONJUNCTION WITH THEIR ORTHO WORKSTATION ID-MTS, AND THAT THEY OBTAINED A DISCREPANT NEGATIVE RESULT. COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST(B)(6), (B)(6) EVENT DATE: 30OCT2025, REPORTED ON THE SAME DAY. ORTHO WORKSTATION ID-MTS, 510011120, INSTALL DATE: 20SEP2022 REAGENTS: MTS ANTI-IGG CARD LOT 052025001-10, EXPIRATION: 11APR2026, MANUFACTURE: 11JUL2025 MTS DILUENT 2 LOT MD197, EXPIRATION: 10APR2026, MANUFACTURE: 10APR2025 SAMPLE INFORMATION: FEMALE, NOT PREGNANT, NO PREVIOUS ANTIBODY HISTORY, NO RECENT TRANSFUSION HISTORY. THE CUSTOMER STATED THAT ONE PATIENT SAMPLE WAS TESTED IN MANUAL GEL METHOD USING THEIR ORTHO WORKSTATION ID-MTS (510011120) IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT 052025001-10 AND MTS DILUENT 2 LOT MD197, WHICH RESULTED IN A NEGATIVE DAT TEST. THE CUSTOMER STATED THAT IT IS THEIR FACILITY POLICY TO TEST ALL FIRST-TIME RH-NEGATIVE PATIENTS FOR WEAK-D, AND IF THE RESULT IS POSITIVE, DAT TESTING IS SUBSEQUENTLY PERFORMED. SINCE THE PATIENT TESTED POSITIVE FOR WEAK-D, THE DAT WAS CONSEQUENTLY PERFORMED ON THE SAME GEL CARD (STILL WARM) AND THE RESULT WAS NEGATIVE. ON THE SAME DAY, THE CUSTOMER RECEIVED A SECOND SAMPLE FROM THIS PATIENT FOR A RETYPE, AS THIS WAS A FIRST-TIME PATIENT. THE SECOND SAMPLE TESTED POSITIVE FOR BOTH WEAK-D AND DAT. THE CUSTOMER STATED THEY REPEATED THE DAT TEST AGAIN WITH A ROOM TEMPERATURE GEL CARD, WHICH RESULTED IN A POSITIVE DAT(1-2+), AND A PRE-WARMED GEL CARD WHICH RESULTED IN A NEGATIVE DAT. THE CUSTOMER STATED THAT A NEGATIVE DAT RESULT WAS ORIGINALLY REPORTED BUT LATER MODIFIED IN THE COMPUTER SYSTEM TO POSITIVE DAT, AFTER TESTING THE SECOND SAMPLE. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1767841	MTS ANTI-IGG CARD 5X20	MTS GEL CARDS - FOR DIRECT AND INDIRECT ANTIGLOBULIN TEST	QHS	MICROTYPING SYSTEMS		052025001-10	10758750005994

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown