ARCHITECT ANTI-HBC II REAGENT KIT
Report
- Report Number
- 3002809144-2024-00108
- Event Type
- Malfunction
- Date Received
- April 11, 2024
- Date of Event
- April 2, 2024
- Report Date
- June 25, 2024
- Manufacturer
- ABBOTT GMBH
- Product Code
- LOM
- UDI-DI
- 00380740162610
- PMA / PMN Number
- LOM
- 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.
THE COMPLAINT EVALUATION 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 OF ARCHITECT ANTI-HBC II REAGENT LOT NUMBER 58123BE02. THE TICKET SEARCH DETERMINED THAT THERE IS AS EXPECTED COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE ARCHITECT ANTI-HBC II COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING A COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (BIOMEX SEROCONVERSION PANEL SCP-HBV-001). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT ANTI-HBC II TEST RESULTS PROVIDED BY BIOMEX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT ANTI-HBC II REAGENT LOT NUMBER 58123BE02.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT ANTI-HBC II RESULT ON ONE 10YRS OLD PATIENT. THE RESULTS WERE PROVIDED: ANTI-HBC=0.95 S/CO (< 1.00=NONREACTIVE) /ON ROCHE=0.787 S/CO (< 1.00 S/CO=REACTIVE) ADDITIONAL INFORMATION PROVIDED: HBSAG=0.710 (REACTIVE) /ROCHE=14.970 (REACTIVE); ANTI-HBS=1.25 (NONREACTIVE) /ROCHE=NONREACTIVE; HBEAG=0.435 (NONREACTIVE) /ROCHE==NONREACTIVE; ANTI-HBE=1.790 (NONREACTIVE) /ROCHE=NONREACTIVE THE CUSTOMER ONLY CONCERN FOR NONREACTIVE ARCHITECT ANTI-HBC II RESULTS WHICH DOES NOT MATCH WITH ROCHE PLATFORM. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT ANTI-HBC II RESULT ON ONE 10YRS OLD PATIENT. THE RESULTS WERE PROVIDED: ANTI-HBC=0.95 S/CO (< 1.00=NONREACTIVE) /ON ROCHE=0.787 S/CO (< 1.00 S/CO=REACTIVE) ADDITIONAL INFORMATION PROVIDED: HBSAG=0.710 (REACTIVE) /ROCHE=14.970 (REACTIVE); ANTI-HBS=1.25 (NONREACTIVE) /ROCHE=NONREACTIVE; HBEAG=0.435 (NONREACTIVE) /ROCHE==NONREACTIVE; ANTI-HBE=1.790 (NONREACTIVE) /ROCHE=NONREACTIVE THE CUSTOMER ONLY CONCERN FOR NONREACTIVE ARCHITECT ANTI-HBC II RESULTS WHICH DOES NOT MATCH WITH ROCHE PLATFORM. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651066 | ARCHITECT ANTI-HBC II REAGENT KIT | TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) | LOM | ABBOTT GMBH | 58123BE02 | 00380740162610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Unknown | ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6) |