ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT
Report
- Report Number
- 3008344661-2025-00033
- Event Type
- Malfunction
- Date Received
- March 20, 2025
- Date of Event
- February 28, 2025
- Report Date
- July 2, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- UDI-DI
- 00380740160609
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION B5 HAS BEEN UPDATED WITH ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 01R64-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 01R64-21/31, WITH 510K/PMA/BLA NUMBER: P210003. A1: PATIENT IDENTIFIER: THE COMPLETE LIST OF SAMPLE ID'S ARE (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
SECTION B5 HAS BEEN UPDATED WITH ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
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. REVIEW OF TRACKING AND TRENDING FOR THE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I HBSAG NEXT QUALITATIVE REAGENT AND COMPLAINT LOT RELATED TO THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED ON THE COMPLAINT LOT, WHICH CONCLUDED ACCEPTANCE CRITERIA WAS MET, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT LOT 65476FZ00 WAS IDENTIFIED.
THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HBSAG NEXT QUALITATIVE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE (SAMPLE ID (B)(6) GENERATED A RESULT OF 390.54 S/CO (REACTIVE). THIS RESULT WAS RELEASED OUT OF THE LABORATORY. 1 WEEK LATER ANOTHER SAMPLE (SAMPLE ID (B)(6) GENERATED A RESULT OF 0.30 S/CO (NON-REACTIVE). THIS RESULT WAS QUESTIONED AS THE IT DID NOT MATCH THE PATIENT RESULT. THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 9.31, 8.32, AND 8.33 S/CO. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION: PATIENT INFORMATION: PATIENT HAS A HISTORY OF HEPATITIS B AND HAS A POSITIVE HBSAG TEST WITH POSITIVE NEUTRALIZATION CONFIRMATORY TESTING. SAMPLE (B)(6) WAS TESTED WITH NEUTRALIZATION CONFIRMATORY TESTING, WHICH WAS REPORTED TO BE POSITIVE.
THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HBSAG NEXT QUALITATIVE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE (SAMPLE ID: (B)(6) GENERATED A RESULT OF 390.54 S/CO (REACTIVE). THIS RESULT WAS RELEASED OUT OF THE LABORATORY. 1 WEEK LATER ANOTHER SAMPLE (SAMPLE ID: (B)(6) GENERATED A RESULT OF 0.30 S/CO (NON-REACTIVE). THIS RESULT WAS QUESTIONED AS THE IT DID NOT MATCH THE PATIENT RESULT. THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 9.31, 8.32, AND 8.33 S/CO. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HBSAG NEXT QUALITATIVE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE (SAMPLE ID (B)(6) GENERATED A RESULT OF 390.54 S/CO (REACTIVE). THIS RESULT WAS RELEASED OUT OF THE LABORATORY. 1 WEEK LATER ANOTHER SAMPLE (SAMPLE ID (B)(6) GENERATED A RESULT OF 0.30 S/CO (NON-REACTIVE). THIS RESULT WAS QUESTIONED AS THE IT DID NOT MATCH THE PATIENT RESULT. THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 9.31, 8.32, AND 8.33 S/CO. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION: PATIENT INFORMATION: PATIENT HAS A HISTORY OF HEPATITIS B AND HAS A POSITIVE HBSAG TEST WITH POSITIVE NEUTRALIZATION CONFIRMATORY TESTING. SAMPLE (B)(6) WAS TESTED WITH NEUTRALIZATION CONFIRMATORY TESTING, WHICH WAS REPORTED TO BE POSITIVE. ADDITIONAL INFORMATION: SAMPLE ID (B)(6) WAS REPEATED AND GENERATED A RESULT OF 391.66 S/CO.
THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HBSAG NEXT QUALITATIVE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: THE FIRST SAMPLE (SAMPLE ID (B)(6) GENERATED A RESULT OF 390.54 S/CO (REACTIVE). THIS RESULT WAS RELEASED OUT OF THE LABORATORY. 1 WEEK LATER ANOTHER SAMPLE (SAMPLE ID (B)(6) GENERATED A RESULT OF 0.30 S/CO (NON-REACTIVE). THIS RESULT WAS QUESTIONED AS THE IT DID NOT MATCH THE PATIENT RESULT. THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 9.31, 8.32, AND 8.33 S/CO. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION: PATIENT INFORMATION: PATIENT HAS A HISTORY OF HEPATITIS B AND HAS A POSITIVE HBSAG TEST WITH POSITIVE NEUTRALIZATION CONFIRMATORY TESTING. SAMPLE (B)(6) WAS TESTED WITH NEUTRALIZATION CONFIRMATORY TESTING, WHICH WAS REPORTED TO BE POSITIVE. ADDITIONAL INFORMATION: SAMPLE ID (B)(6) WAS REPEATED AND GENERATED A RESULT OF 391.66 S/CO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1306743 | ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 65476FZ00 | 00380740160609 |
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)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)6) |