ARCHITECT ANTI-HBC II
Report
- Report Number
- 3002809144-2025-00238
- Event Type
- Injury
- Date Received
- July 21, 2025
- Date of Event
- October 20, 2024
- Report Date
- August 6, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- LOM
- UDI-DI
- 00380740017767
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT ANTI-HBC II ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. IN-HOUSE TESTING TO INVESTIGATE THE SENSITIVITY PERFORMANCE COULD NOT BE PERFORMED AS REAGENT LOT 59089BE00 EXPIRED ON 15-NOV-2024. REVIEW OF STATISTICAL PROCESS CONTROL (SPC) DATA: THE POSITIVE CONTROL (PC) VALUE OBTAINED FOR LOT 59089BE00 WAS WELL WITHIN BOTH THE RELEASE SPECIFICATIONS AND THE SPC CONTROL LIMITS, INDICATING ACCEPTABLE PERFORMANCE. ADDITIONALLY, THE PC VALUES FOR LOTS 59089BE00 AND 70154BE00 WERE IDENTICAL, DEMONSTRATING ACCEPTABLE PERFORMANCE OF THE COMPLAINT LOT. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HBC II REAGENT WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT ANTI-HBC RESULTS ON A MALE TRANSPLANT DONOR PATIENT SAMPLE ON (B)(6) 2024. BOTH THE DONOR PATIENT AND THE TRANSPLANT RECIPIENT PATIENT TESTED NEGATIVE FOR HBSAG AND ANTI-HBC IN (B)(6) 2024. IN (B)(6) 2025, THE TRANSPLANT RECIPIENT PATIENT TESTED POSITIVE FOR HBSAG. THE DONOR TESTING SAMPLES (SID (B)(6) WERE TESTED (B)(6) 2024, AND THE ARCHITECT ANTI-HBC RESULTS WERE 0.88 / 0.88 / 0.92 S/CO (NONREACTIVE). THE HBSAG RESULTS WERE 0.17, 0.18, 0.19 S/CO (NONREACTIVE). THE DONOR SAMPLE WAS RETESTED FOR ANTI-HBC AT CHUM ON (B)(6) 2025 AFTER UNFREEZING AND THE RESULT WAS REACTIVE (1.03, 1.015, 1.028 S/CO). THE DATE OF THE TRANSPLANT OPERATION (FOR ANONYMOUS ORGAN SAMPLE SID (B)(6) IS UNKNOWN. IN (B)(6) 2025, THE TRANSPLANT RECIPIENT TESTED NEGATIVE FOR ANTI-HBC ANTIBODIES BUT HAD HIGH LEVEL OF HBSAG (SPECIFIC RESULT VALUES NOT PROVIDED). THE RECIPIENT HAS BEEN DIAGNOSED WITH ACUTE HEPATITIS POST-TRANSPLANT FROM A CARRIER DONOR LESS THAN ONE YEAR FROM THE TRANSPLANT OPERATION. THE TRANSPLANT RECIPIENT IS CURRENTLY UNDERGOING HEPATITIS B TREATMENT.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT ANTI-HBC RESULTS ON A MALE TRANSPLANT DONOR PATIENT SAMPLE ON (B)(6) 2024. BOTH THE DONOR PATIENT AND THE TRANSPLANT RECIPIENT PATIENT TESTED NEGATIVE FOR HBSAG AND ANTI-HBC IN (B)(6) 2024. IN (B)(6) 2025, THE TRANSPLANT RECIPIENT PATIENT TESTED POSITIVE FOR HBSAG. THE DONOR TESTING SAMPLES (SID (B)(6) WERE TESTED (B)(6) 2024, AND THE ARCHITECT ANTI-HBC RESULTS WERE 0.88 / 0.88 / 0.92 S/CO (NONREACTIVE). THE HBSAG RESULTS WERE 0.17, 0.18, 0.19 S/CO (NONREACTIVE). THE DONOR SAMPLE WAS RETESTED FOR ANTI-HBC AT CHUM ON (B)(6) 2025 AFTER UNFREEZING AND THE RESULT WAS REACTIVE (1.03, 1.015, 1.028 S/CO). THE DATE OF THE TRANSPLANT OPERATION (FOR ANONYMOUS ORGAN SAMPLE SID (B)(6) IS UNKNOWN. IN (B)(6) 2025, THE TRANSPLANT RECIPIENT TESTED NEGATIVE FOR ANTI-HBC ANTIBODIES BUT HAD HIGH LEVEL OF HBSAG (SPECIFIC RESULT VALUES NOT PROVIDED). THE RECIPIENT HAS BEEN DIAGNOSED WITH ACUTE HEPATITIS POST-TRANSPLANT FROM A CARRIER DONOR LESS THAN ONE YEAR FROM THE TRANSPLANT OPERATION. THE TRANSPLANT RECIPIENT IS CURRENTLY UNDERGOING HEPATITIS B TREATMENT. THE CUSTOMER STATED THAT HBV VIREMIA CONFIRMED BY COBAS HBV DNA TEST: 39,000 UI/ML. THE RECIPIENT WAS SUSPECT OF ACUTE HEPATITIS DUE TO HIGH HEPATIC ENZYMES MARKERS DURING A PRE-SCREENING FOR BIOLOGICS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2753263 | ARCHITECT ANTI-HBC II | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT GMBH | 59089BE00 | 00380740017767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Disability | ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6) |