ARCHITECT ANTI-TPO
Report
- Report Number
- 3008344661-2025-00129
- Event Type
- Malfunction
- Date Received
- September 11, 2025
- Date of Event
- September 4, 2025
- Report Date
- October 20, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- JZO
- UDI-DI
- 00380740003470
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K47-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K47-27, WITH 510K/PMA/BLA NUMBER K052407. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
UPDATED TO INCLUDE DATES FOR D4 - EXPIRATION DATE AND H4 - DEVICE MFG DATE. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT ANTI-TPO ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 42254UN24. A DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. IN HOUSE ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF REAGENT LOT 42254UN24. AN INTERNAL ARCHITECT ANTI-TPO PANEL SET WAS TESTED WITH A RETAINED KIT OF LOT 42254UN24. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-TPO REAGENT LOT 42254UN24 WAS IDENTIFIED.
THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT ANTI-TPO RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 26-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CHRONIC HIVES. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0 TO 5.61 IU/ML. INITIAL ARCHITECT ANTI-TPO RESULT = 800.24 IU/ML. REPEAT #1 RESULT = 0.00 IU/ML. REPEAT #2 RESULT (POST HIGH-SPEED CENTRIFUGATION) = 839.12 IU/ML. OTHER RESULT PROVIDED: ANTI-TG RESULT = 63.66 IU/ML (REFERENCE RANGE: 0 TO 4.11 IU/ML). THE CUSTOMER CONSIDERED THE INITIAL ANTI-TPO RESULT OF 800.24 IU/ML TO BE CONSISTENT WITH THE PATIENT¿S CLINICAL PRESENTATION AND RELEASED IT TO THE PHYSICIAN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT ANTI-TPO RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 26-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CHRONIC HIVES. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0 TO 5.61 IU/ML. INITIAL ARCHITECT ANTI-TPO RESULT = 800.24 IU/ML. REPEAT #1 RESULT = 0.00 IU/ML. REPEAT #2 RESULT (POST HIGH-SPEED CENTRIFUGATION) = 839.12 IU/ML. OTHER RESULT PROVIDED: ANTI-TG RESULT = 63.66 IU/ML (REFERENCE RANGE: 0 TO 4.11 IU/ML). THE CUSTOMER CONSIDERED THE INITIAL ANTI-TPO RESULT OF 800.24 IU/ML TO BE CONSISTENT WITH THE PATIENT¿S CLINICAL PRESENTATION AND RELEASED IT TO THE PHYSICIAN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2675018 | ARCHITECT ANTI-TPO | SYSTEM, TEST, THYROID AUTOANTIBODY | JZO | ABBOTT IRELAND DIAGNOSTICS DIVISION | 42254UN24 | 00380740003470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | ARC I2000SR INST, 03M74-02,(B)(6)| ARC I2000SR INST, 03M74-02,(B)(6) |