ARCHITECT ANTI-HBS REAGENT KIT
Report
- Report Number
- 3008344661-2024-00113
- Event Type
- Malfunction
- Date Received
- September 11, 2024
- Date of Event
- February 23, 2024
- Report Date
- January 27, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- UDI-DI
- 00380740138080
- PMA / PMN Number
- P050051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTED DATA FOUND IN SECTION H6 MEDICAL DEVICE PROBLEM CODE, CHANGED FROM A090804 TO A090809.
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, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. 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 TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT ANTI-HBS REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 58537FN00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HBS REAGENT LOT 58537FN00 WAS IDENTIFIED.
CORRECTED DATA FOUND IN SECTION D4 CATALOG # AND LOT #.
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT ANTI-HBS RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID (B)(6) ANTI-HBS 12.03 MIU/ML (REFERENCE RANGE 0-10 MIU/ML), OTHER RESULTS PROVIDED: HBSAG 0.18 S/CO (NONREACTIVE), ANTI-HBC 0.12 S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT ANTI-HBS RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) ANTI-HBS 12.03 MIU/ML (REFERENCE RANGE 0-10 MIU/ML), OTHER RESULTS PROVIDED: HBSAG 0.18 S/CO (NONREACTIVE), ANTI-HBC 0.12 S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT ANTI-HBS RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6)2024 SID CC (B)(6) ANTI-HBS 12.03 MIU/ML (REFERENCE RANGE 0-10 MIU/ML), OTHER RESULTS PROVIDED: HBSAG 0.18 S/CO (NONREACTIVE), ANTI-HBC 0.12 S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT ANTI-HBS RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6). ANTI-HBS 12.03 MIU/ML (REFERENCE RANGE 0-10 MIU/ML), OTHER RESULTS PROVIDED: HBSAG 0.18 S/CO (NONREACTIVE), ANTI-HBC 0.12 S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1584733 | ARCHITECT ANTI-HBS REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 58537FN00 | 00380740138080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ARC I1000SR INTGR, 01L86-40, (B)(6)| ARC I1000SR INTGR, 01L86-40, (B)(6)| ARC I1000SR INTGR, 01L86-40, (B)(6)| ARC I1000SR INTGR, 01L86-40, (B)(6) |