ALINITY I TOXO IGG REAGENT KIT
Report
- Report Number
- 3002809144-2024-00338
- Event Type
- Malfunction
- Date Received
- November 27, 2024
- Date of Event
- November 11, 2024
- Report Date
- December 16, 2024
- 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
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 COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR COMPLAINT LOT. 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 66438BE00 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 66438BE00 WAS IDENTIFIED.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P45-22 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 CUSTOMER REPORTED FALSE ELEVATED ALINITY I TOXO IGG AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE: POSITIVITY CUTOFF IS 1.2 IU/ML. SAMPLE ID (B)(6), INITIAL RESULT WAS 3.639 AND REPEAT RESULTS WERE 0.064 & 0.643. SAMPLE ID (B)(6), INITIAL RESULT WAS 10.516 AND REPEAT RESULTS WERE 0.062, 0.066 & 0.084. SAMPLE ID (B)(6), INITIAL RESULT WAS 2.053 AND REPEAT RESULTS WERE 0.079 & 0.127. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER REPORTED FALSE ELEVATED ALINITY I TOXO IGG AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE: POSITIVITY CUTOFF IS 1.2 IU/ML. SAMPLE ID (B)(6), INITIAL RESULT WAS 3.639 AND REPEAT RESULTS WERE 0.064 & 0.643. SAMPLE ID (B)(6), INITIAL RESULT WAS 10.516 AND REPEAT RESULTS WERE 0.062, 0.066 & 0.084. SAMPLE ID (B)(6), INITIAL RESULT WAS 2.053 AND REPEAT RESULTS WERE 0.079 & 0.127. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2614214 | ALINITY I TOXO IGG REAGENT KIT | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | LGD | ABBOTT GMBH | 66438BE00 |
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) |