ARCHITECT HBSAG QUALITATIVE II REAGENT KIT
Report
- Report Number
- 3008344661-2023-00157
- Event Type
- Malfunction
- Date Received
- August 21, 2023
- Date of Event
- August 1, 2023
- Report Date
- September 11, 2023
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- PMA / PMN Number
- P110029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ARCHITECT HBSAG QUALITATIVE II RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED WITHIN THE ARTICLE, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES WITH LIST NUMBER 02G22 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE LOT NUMBER(S) ARE UNKNOWN IN THIS CASE, HOWEVER REVIEW OF THE WITHIN DATE LOTS WITH AT LEAST 2000 PATIENT RESULTS SHOW THAT ALL MEDIAN VALUES ARE WITHIN ±3SD OF THE MEAN INDICATING THAT THE LOTS ARE COMPARABLE AND PERFORMING ACCEPTABLY IN THE FIELD. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT HBSAG QUALITATIVE II REAGENT WAS IDENTIFIED.
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 02G22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53.
A LITERATURE ARTICLE BY ARUL PRAKASH, SURESH PONNUVEL, JOHN DICKSON CALVIN DEVADASAN, KARTHIK NITHYANANDHAN, ABIRAMI BASKARAN, RUNAL JOHN STEVE, T. KALPANA, BAKTHALAL SINGH, ASHISH GOEL, UDAY GEORGE ZACHARIAH, C E EAPEN , RAJESH KANNANGAI, PRIYA ABRAHAM, AND GNANADURAI JOHN FLETCHER, ¿ARCHITECT HBSAG NEXT ASSAY IS POSITIONED BETTER TO RESOLVE AND REFINE CHALLENGING WEAK REACTIVE CLINICAL SAMPLES¿, JOURNAL OF CLINICAL VIROLOGY : THE OFFICIAL PUBLICATION OF THE PAN AMERICAN SOCIETY FOR CLINICAL VIROLOGY 166 : 105524. (JUN 26, 2023), DOCUMENTED A FALSE NONREACTIVE ARCHITECT HBSAG QUALITATIVE II RESULT FOR ONE SAMPLE. THE STUDY NOTED A TOTAL OF 99,761 SERUM SAMPLES WERE RECEIVED FOR ROUTINE ARCHITECT HBSAG QUALITATIVE II TESTING FROM BOTH OUT PATIENTS AND IN-PATIENTS BETWEEN JANUARY 2022 AND 2023. 248 OF THESE SAMPLES WERE INITIAL REACTIVE, AND 68 SAMPLES BECAME NONREACTIVE ON REPEAT TESTING (IN DUPLICATE). ALL SAMPLES WERE THEN TESTED WITH THE ARCHITECT NEXT QUALITATIVE ASSAY. ONE SAMPLE WAS REACTIVE WITH THE ARCHITECT NEXT QUALITATIVE ASSAY BUT WAS NONREACTIVE WITH THE ARCHITECT HBSAG QUALITATIVE II ASSAY AND THE PATIENT WAS CLINICALLY DIAGNOSED WITH CHRONIC HBV INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
A LITERATURE ARTICLE BY ARUL PRAKASH, SURESH PONNUVEL, JOHN DICKSON CALVIN DEVADASAN, KARTHIK NITHYANANDHAN, ABIRAMI BASKARAN, RUNAL JOHN STEVE, T. KALPANA, BAKTHALAL SINGH, ASHISH GOEL, UDAY GEORGE ZACHARIAH, C E EAPEN , RAJESH KANNANGAI, PRIYA ABRAHAM, AND GNANADURAI JOHN FLETCHER, ¿ARCHITECT HBSAG NEXT ASSAY IS POSITIONED BETTER TO RESOLVE AND REFINE CHALLENGING WEAK REACTIVE CLINICAL SAMPLES¿, JOURNAL OF CLINICAL VIROLOGY : THE OFFICIAL PUBLICATION OF THE PAN AMERICAN SOCIETY FOR CLINICAL VIROLOGY 166 : 105524. (JUN 26, 2023), DOCUMENTED A FALSE NONREACTIVE ARCHITECT HBSAG QUALITATIVE II RESULT FOR ONE SAMPLE. THE STUDY NOTED A TOTAL OF 99,761 SERUM SAMPLES WERE RECEIVED FOR ROUTINE ARCHITECT HBSAG QUALITATIVE II TESTING FROM BOTH OUT PATIENTS AND IN-PATIENTS BETWEEN JANUARY 2022 AND 2023. 248 OF THESE SAMPLES WERE INITIAL REACTIVE, AND 68 SAMPLES BECAME NONREACTIVE ON REPEAT TESTING (IN DUPLICATE). ALL SAMPLES WERE THEN TESTED WITH THE ARCHITECT NEXT QUALITATIVE ASSAY. ONE SAMPLE WAS REACTIVE WITH THE ARCHITECT NEXT QUALITATIVE ASSAY BUT WAS NONREACTIVE WITH THE ARCHITECT HBSAG QUALITATIVE II ASSAY AND THE PATIENT WAS CLINICALLY DIAGNOSED WITH CHRONIC HBV INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1785806 | ARCHITECT HBSAG QUALITATIVE II REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ARC I2K PROC MOD, 03M74-01, (B)(6) | ARC I2K PROC MOD, 03M74-01, (B)(6) |