ALINITY I ANTI-HBC II REAGENT KIT
Report
- Report Number
- 3002809144-2025-00040
- Event Type
- Malfunction
- Date Received
- February 10, 2025
- Date of Event
- January 21, 2025
- Report Date
- March 26, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- LOM
- UDI-DI
- 00380740130022
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, WITH 510K/PMA/BLA NUMBER P080023.
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY INCREASE IN COMPLAINTS FOR THE COMPLAINT ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE ALINITY I ANTI-HBC II COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING A COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (BIOMEX SEROCONVERSION PANEL SCP-HBV-001). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT ANTI-HBC II TEST RESULTS PROVIDED BY BIOMEX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANEL. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. NOTE: ALINITY I ANTI-HBC II AND ARCHITECT ANTI-HBC II UTILIZE THE SAME REAGENTS AND SAMPLE/REAGENT RATIOS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HBC II REAGENT LOT 63357BE00 WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I ANTI-HBC RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 0.82 S/CO (NONREACTIVE), REPEAT ON ANOTHER ALINITY = 0.97 S/CO (NONREACTIVE), REPEAT WITH COBAS = 0.669 COI (POSITIVE). HISTORICAL RESULT-HBSAG POSITIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I ANTI-HBC RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 0.82 S/CO (NONREACTIVE), REPEAT ON ANOTHER ALINITY = 0.97 S/CO (NONREACTIVE), REPEAT WITH COBAS = 0.669 COI (POSITIVE). HISTORICAL RESULT-HBSAG POSITIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 871551 | ALINITY I ANTI-HBC II REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT GMBH | 63357BE00 | 00380740130022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |