ARCHITECT HBSAG
Report
- Report Number
- 3008344661-2025-00087
- Event Type
- Malfunction
- Date Received
- June 23, 2025
- Date of Event
- January 1, 2017
- Report Date
- August 28, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- UDI-DI
- 00380740115678
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, WITH 510K/PMA/BLA NUMBER P110029.
DATA AND INFORMATION PROVIDED WITH THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. DATA AND INFORMATION WITHIN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT HBSAG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES WITH THE ASSAY AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IN THIS CASE, THE PATTERN OF SPECIFIC MARKERS IN THIS SAMPLE MOST LIKELY REPRESENTS OCCULT HEPATITIS B INFECTION WITH MUTATIONS BEING A LIKELY CAUSE OF THE OBSERVED NONREACTIVE RESULT. REVIEW OF THE PUBLICATIONS, H. W. REESINK ET AL., ¿OCCULT HEPATITIS B INFECTION IN BLOOD DONORS¿, VOX SANGUINIS (2008) 94 , 153¿166 AND MICHAEL TORBENSON ET AL., ¿OCCULT HEPATITIS B IN HCV+¿, LANCET INFECT DIS 2002; 2: 479¿86, OCCULT HBV INFECTION IS A KNOWN PHENOMENON AND IS DIAGNOSED WHEN A HBV DNA TEST IS POSITIVE BUT HBSAG IS UNDETECTED. THE INFORMATION PRESENTED OF THE VIRUS HAVING COMBINED MULTIPLE MUTATIONS IN THE ANTIGENIC REGION OF THE HBSAG GENE REINFORCES THAT THIS REPRESENTS A KNOWN ESCAPE MUTANT. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT HBSAG ASSAY WAS IDENTIFIED.
SECTION H MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM A090803 TO A090810.
A CONFERENCE SUBMISSION BY L. ZHOU, M P DELCOURT, JM PAWLOTSKY, AND D CANDOTTI, ¿UNUSUAL COMPLEX HEPATITIS B SURFACE PROTEIN VARIANT IN A BLOOD DONOR LEADING TO FALSE-NEGATIVE REACTIVITY WITH A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY¿, ISBTABS25-1023, DOCUMENTED FALSE NONREACTIVE ARCHITECT HBSAG RESULTS FOR A BLOOD DONOR. THE CONFERENCE SUBMISSION AND PRESENTATION NOTED A 63 YEAR OLD MALE BLOOD DONOR THAT WAS UNVACCINATED FOR HBV WHO HAD A POSITIVE VIRAL LOAD OF 16 IU/ML AND TESTED NONREACTIVE WITH THE ARCHITECT HBSAG AND PRISM HBSAG IN 2017. ADDITIONAL TESTING WITH ENZYMATIC IMMUNOASSAYS (EIA) GENERATED REACTIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
A CONFERENCE SUBMISSION BY L. ZHOU, M P DELCOURT, JM PAWLOTSKY, AND D CANDOTTI, ¿UNUSUAL COMPLEX HEPATITIS B SURFACE PROTEIN VARIANT IN A BLOOD DONOR LEADING TO FALSE-NEGATIVE REACTIVITY WITH A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY¿, ISBTABS25-1023, DOCUMENTED FALSE NONREACTIVE ARCHITECT HBSAG RESULTS FOR A BLOOD DONOR. THE CONFERENCE SUBMISSION AND PRESENTATION NOTED A 63 YEAR OLD MALE BLOOD DONOR THAT WAS UNVACCINATED FOR HBV WHO HAD A POSITIVE VIRAL LOAD OF 16 IU/ML AND TESTED NONREACTIVE WITH THE ARCHITECT HBSAG AND PRISM HBSAG IN 2017. ADDITIONAL TESTING WITH ENZYMATIC IMMUNOASSAYS (EIA) GENERATED REACTIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
A CONFERENCE SUBMISSION BY L. ZHOU, M P DELCOURT, JM PAWLOTSKY, AND D CANDOTTI, ¿UNUSUAL COMPLEX HEPATITIS B SURFACE PROTEIN VARIANT IN A BLOOD DONOR LEADING TO FALSE-NEGATIVE REACTIVITY WITH A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY¿, ISBTABS25-1023, DOCUMENTED FALSE NONREACTIVE ARCHITECT HBSAG RESULTS FOR A BLOOD DONOR. THE CONFERENCE SUBMISSION AND PRESENTATION NOTED A 63 YEAR OLD MALE BLOOD DONOR THAT WAS UNVACCINATED FOR HBV WHO HAD A POSITIVE VIRAL LOAD OF 16 IU/ML AND TESTED NONREACTIVE WITH THE ARCHITECT HBSAG AND PRISM HBSAG IN 2017. ADDITIONAL TESTING WITH ENZYMATIC IMMUNOASSAYS (EIA) GENERATED REACTIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 927733 | ARCHITECT HBSAG | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 00380740115678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | ARC I2K PROC MOD, 03M74-01, 116UNKNOWND11.| ARC I2K PROC MOD, 03M74-01, 116UNKNOWND11.| ARC I2K PROC MOD, 03M74-01, 116UNKNOWND11. |