ALINITY I TOXO IGG REAGENT KIT
Report
- Report Number
- 3002809144-2025-00095
- Event Type
- Malfunction
- Date Received
- March 18, 2025
- Date of Event
- January 22, 2025
- Report Date
- April 3, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- LGD
- UDI-DI
- 00380740131258
- PMA / PMN Number
- K210596
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40/ -45, WITH 510K NUMBER K210596. 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.
ADDITIONAL INFORMATION WAS ADDED TO SECTION B5 - DESCRIBE EVENT OR PROBLEM. 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, FIELD DATA REVIEW AND LABELING 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 TRENDING REVIEW FOR THE ALINITY I TOXO IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. THE SEARCH FOR SIMILAR COMPLAINTS FOR THE COMPLAINT LOT DID NOT IDENTIFY AN INCREASED IN COMPLAINT ACTIVITY. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOXO IGG LOT 69139BE00 WAS IDENTIFIED.
UPDATE TO SECTION A2 - AGE AT TIME OF EVENT FROM BLANK TO 32. UPDATE TO SECTION A2 - AGE UNITS (PATIENT) FROM BLANK TO YEARS. UPDATE TO SECTION B3 - DATE OF EVENT FROM 3MAR2025 TO 22JAN2025. UPDATE TO SECTION B5 - DESCRIBE EVENT OR PROBLEM TO INCLUDE ADDITIONAL PATIENT INFORMATION. AN EVALUATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I TOXO IGG FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL TOXO IGG RESULT= 30 IU/ML (SIMILAR TO PREVIOUS MONTH¿S RESULT); AVIDITY TESTING WAS SENT OUT TO A REFERENCE LAB, TOXO IGG RESULT (UNKNOWN METHOD) = NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I TOXO IGG FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL TOXO IGG RESULT= 30 IU/ML (SIMILAR TO PREVIOUS MONTH¿S RESULT); AVIDITY TESTING WAS SENT OUT TO A REFERENCE LAB, TOXO IGG RESULT (UNKNOWN METHOD) = NEGATIVE. UPDATE, ADDITIONAL INFORMATION WAS PROVIDED ON 18MAR2025. 32-YEAR-OLD FEMALE, PRENATAL PATIENT ON (B)(6)2025, INITIAL TOXO IGG RESULT= 35.56 IU/ML: REPEAT RESULT= 34.5 IU/ML. ON (B)(6)2025, TOXO IGG RESULT= 36.1 IU/ML. ON (B)(6)2023, HISTORICAL RESULT (PRATERIA TEST METHOD) = NEGATIVE. UPDATE, ADDITIONAL RESULTS WERE PROVIDED ON 02APR2025. RESULTS FROM THE REFERENCE LABORATORY= 29.7 IU/ML. THE HETEROPHILE ANTIBODY BLOCKER TUBE HAD NO SIGNIFICANT DECREASE IN THE MEASUREMENT VALUE OBSERVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I TOXO IGG FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL TOXO IGG RESULT= 30 IU/ML (SIMILAR TO PREVIOUS MONTH¿S RESULT); AVIDITY TESTING WAS SENT OUT TO A REFERENCE LAB, TOXO IGG RESULT (UNKNOWN METHOD)= NEGATIVE. UPDATE, ADDITIONAL INFORMATION WAS PROVIDED ON 18MAR2025. 32-YEAR-OLD FEMALE, PRENATAL PATIENT. (B)(6) 2025, INITIAL TOXO IGG RESULT= 35.56 IU/ML; REPEAT RESULT= 34.5 IU/ML. (B)(6) 2025, TOXO IGG RESULT= 36.1 IU/ML. (B)(6) 2023, HISTORICAL RESULT (PRATERIA TEST METHOD)= NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 884504 | ALINITY I TOXO IGG REAGENT KIT | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | LGD | ABBOTT GMBH | 69139BE00 | 00380740131258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |