ARCHITECT ANTI-HBS REAGENT KIT
Report
- Report Number
- 3008344661-2024-00087
- Event Type
- Malfunction
- Date Received
- July 29, 2024
- Date of Event
- July 19, 2024
- Report Date
- November 4, 2024
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- LOM
- UDI-DI
- 00380740159948
- PMA / PMN Number
- P050051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7C18 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L82 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
THE COMPLAINT INVESTIGATION FOR FALSELY REACTIVE ARCHITECT ANTI-HBS RESULTS 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 CONFIRM THE COMPLAINT ISSUE. TICKET SEARCH BY LOT INDICATED THE REAGENT LOT IS PERFORMING AS EXPECTED FOR THIS PRODUCT. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE UNDER REVIEW. DEVICE HISTORY RECORD REVIEW FOR LOT 58537FN01 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ARCHITECT ANTI-HBS REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN RESULT FOR THE LOT IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND WITHIN ESTABLISHED BASELINES, CONFIRMING NO SYSTEMIC ISSUE FOR THE PRODUCT 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 ASSAY FOR LOT NUMBER 58537FN01 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT ANTI-HBS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (THE CUSTOMER PROVIDED REFERENCE RANGE WAS 0-10 MIU/ML) INITIAL TEST RESULT = 9.95 MIU/ML, REPEAT RESULTS = 107.29 MIU/ML AND 91.95 MIU/ML THE COLLOIDAL GOLD RESULT = NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT ANTI-HBS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (THE CUSTOMER PROVIDED REFERENCE RANGE WAS 0-10 MIU/ML) INITIAL TEST RESULT = 9.95 MIU/ML, REPEAT RESULTS = 107.29 MIU/ML AND 91.95 MIU/ML THE COLLOIDAL GOLD RESULT = NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 995343 | ARCHITECT ANTI-HBS REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT IRELAND DIAGNOSTICS DIVISION | 58537FN01 | 00380740159948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ARC I2000SR INST, 03M74-02, ISR61072| ARC I2000SR INST, 03M74-02, ISR61072 |