ALINITY I TSH REAGENT KIT
Report
- Report Number
- 3005094123-2023-00124
- Event Type
- Malfunction
- Date Received
- May 11, 2023
- Date of Event
- February 4, 2022
- Report Date
- August 2, 2023
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- JLW
- UDI-DI
- 00380740131159
- PMA / PMN Number
- K983442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION REGARDING FALSELY DECREASED ALINITY I TSH REAGENT LOT 45295UD00 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 YET AVAILABLE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET AND TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES OR DEVIATIONS. THE OVERALL PERFORMANCE OF THE ALINITY I TSH REAGENT WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE REVIEW OF FIELD DATA DETERMINED THE MEDIAN PATIENT RESULTS FOR LOT 45295UD00 ARE COMPARABLE WITH OTHER LOTS IN THE FIELD, INDICATING NO SYSTEMIC ISSUE FOR THE LOT. A LABELING REVIEW DETERMINED PRODUCT LABELING PROVIDES ADEQUATE INFORMATION REGARDING THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TSH REAGENT LOT 45295UD00 WAS IDENTIFIED.
A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID'S (B)(6). 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.
THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS OF ALINITY I TSH FOR 1 PATIENT AND PROVIDED THE FOLLOWING DATA (REFERENCE RANGE IS 0.3 ¿ 5 MU/L). ON 4-FEB-22 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.15, FREE T4 (PMOL/L) RESULT WAS 12.2, FREE T3 (PMOL/L) RESULT WAS 4.3. ON 22-APR-22 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.133, FREE T4 (PMOL/L) RESULT WAS 13.3, FREE T3 (PMOL/L) RESULT WAS 4.7. ON 16-JUN-22 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.18, FREE T4 (PMOL/L) RESULT WAS 13.4, FREE T3 (PMOL/L) RESULT WAS 5. ON 21-OCT-22 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.163, FREE T4 (PMOL/L) RESULT WAS 11.7, FREE T3 (PMOL/L) RESULT WAS 4.3. ON 7-DEC-22 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.121, FREE T4 (PMOL/L) RESULT WAS 13.5, FREE T3 (PMOL/L) RESULT WAS NOT TESTED. ON 30-MAR-23 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS0.146, FREE T4 (PMOL/L) RESULT WAS 15.8, FREE T3 (PMOL/L) RESULT WAS 4.8. THE PATIENT HAD SAMPLES SENT TO OTHER LABORATORIES AND GENERATED RESULTS ON DIFFERENT ANALYZER PLATFORMS: ROCHE PLATFORM (REFERENCE RANGE IS 0.27 ¿ 4.2 MU/L AND NOT DATES PROVIDED) TSH (MU/L) RESULT WAS 0.952, FREE T4 (PMOL/L) RESULT WAS 19.7, FREE T3 (PMOL/L) RESULT WAS 5.16. TSH (MU/L) RESULT WAS 0.982, FREE T4 (PMOL/L) RESULT WAS 19.7, FREE T3 (PMOL/L) RESULT WAS 5.16 BECKMAN PLATFORM: (NO REFERENCE RANGE PROVIDED). TSH (MU/L) RESULT WAS 0.885, FREE T4 (PMOL/L) RESULT WAS 16.7, FREE T3 (PMOL/L) RESULT WAS 4.89 DATE: FROM 4 APR 2023. THE CUSTOMER FURTHER REPORTED THAT HAMA ANTIBODIES WERE NEGATIVE, HETEROPHILIC ANTIBODIES WERE NOT TESTED, AND SAMPLES FROM THE PATIENT WERE VISUALLY UNREMARKABLE (NOT ICTERIC, NO LIPEMIA OR HEMOLYSIS). THE CUSTOMER DOES BELIEVE THAT A PATIENT SPECIFIC INTERFERENCE IS UNLIKELY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS OF ALINITY I TSH FOR 1 PATIENT AND PROVIDED THE FOLLOWING DATA (REFERENCE RANGE IS 0.3 ¿ 5 MU/L). ON (B)(6) 2022 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.15, FREE T4 (PMOL/L) RESULT WAS 12.2, FREE T3 (PMOL/L) RESULT WAS 4.3. ON (B)(6) 2022 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.133, FREE T4 (PMOL/L) RESULT WAS 13.3, FREE T3 (PMOL/L) RESULT WAS 4.7. ON (B)(6) 2022 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.18, FREE T4 (PMOL/L) RESULT WAS 13.4, FREE T3 (PMOL/L) RESULT WAS 5. ON (B)(6) 2022 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.163, FREE T4 (PMOL/L) RESULT WAS 11.7, FREE T3 (PMOL/L) RESULT WAS 4.3. ON (B)(6) 2022 SAMPLE ID (B)(6) TSH (MU/L) RESULT WAS 0.121, FREE T4 (PMOL/L) RESULT WAS 13.5, FREE T3 (PMOL/L) RESULT WAS NOT TESTED. ON (B)(6) 2023 SAMPLE ID (B)(6)TSH (MU/L) RESULT WAS0.146, FREE T4 (PMOL/L) RESULT WAS 15.8, FREE T3 (PMOL/L) RESULT WAS 4.8. THE PATIENT HAD SAMPLES SENT TO OTHER LABORATORIES AND GENERATED RESULTS ON DIFFERENT ANALYZER PLATFORMS: ROCHE PLATFORM (REFERENCE RANGE IS 0.27 ¿ 4.2 MU/L AND NOT DATES PROVIDED). TSH (MU/L) RESULT WAS 0.952, FREE T4 (PMOL/L) RESULT WAS 19.7, FREE T3 (PMOL/L) RESULT WAS 5.16. TSH (MU/L) RESULT WAS 0.982, FREE T4 (PMOL/L) RESULT WAS 19.7, FREE T3 (PMOL/L) RESULT WAS 5.16. BECKMAN PLATFORM: (NO REFERENCE RANGE PROVIDED). TSH (MU/L) RESULT WAS 0.885, FREE T4 (PMOL/L) RESULT WAS 16.7, FREE T3 (PMOL/L) RESULT WAS 4.89. DATE: FROM (B)(6) 2023. THE CUSTOMER FURTHER REPORTED THAT HAMA ANTIBODIES WERE NEGATIVE, HETEROPHILIC ANTIBODIES WERE NOT TESTED, AND SAMPLES FROM THE PATIENT WERE VISUALLY UNREMARKABLE (NOT ICTERIC, NO LIPEMIA OR HEMOLYSIS). THE CUSTOMER DOES BELIEVE THAT A PATIENT SPECIFIC INTERFERENCE IS UNLIKELY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1164904 | ALINITY I TSH REAGENT KIT | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | JLW | ABBOTT IRELAND DIAGNOSTICS DIVISION | 07P4830 | 45295UD00 | 00380740131159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ALNTY I PROCESSING MODU, 03R65-01, AI01774| ALNTY I PROCESSING MODU, 03R65-01, AI01774 |