ALINITY I TOXO IGG REAGENT KIT
Report
- Report Number
- 3002809144-2025-00127
- Event Type
- Malfunction
- Date Received
- April 8, 2025
- Date of Event
- March 7, 2025
- Report Date
- April 9, 2025
- Manufacturer
- ABBOTT GMBH
- Product Code
- LGD
- PMA / PMN Number
- K210596
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P45-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40 / 45, WITH 510K/PMA/BLA NUMBER K210596. A1 PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID'S ARE (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE COMPLAINT INVESTIGATION 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 WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE REPORTED EVENT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 64052BE00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. 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 REAGENT LOT 64052BE00 WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I TOXO IGG GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: PATIENT 1: ON (B)(6) 2025: SAMPLE ID (B)(6), RESULT WAS 11.6 IU/ML (REACTIVE) AND REPEAT RESULT WAS LESS THAN 0.2 IU/ML (NON-REACTIVE). PATIENT 2: ON (B)(6) 2025: SAMPLE ID (B)(6), RESULT WAS 7.3 IU/ML (REACTIVE). WHEN THE SERUM SAMPLE WAS REPEATED ON (B)(6) 2025, THE RESULT WAS 1.1 IU/ML (NON-REACTIVE). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I TOXO IGG GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: PATIENT 1: ON (B)(6) 2025: SAMPLE ID (B)(6), RESULT WAS 11.6 IU/ML (REACTIVE) AND REPEAT RESULT WAS LESS THAN 0.2 IU/ML (NON-REACTIVE). PATIENT 2: ON (B)(6) 2025: SAMPLE ID (B)(6), RESULT WAS 7.3 IU/ML (REACTIVE). WHEN THE SERUM SAMPLE WAS REPEATED ON (B)(6) 2025, THE RESULT WAS 1.1 IU/ML (NON-REACTIVE). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727833 | ALINITY I TOXO IGG REAGENT KIT | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | LGD | ABBOTT GMBH | 64052BE00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |