ALINITY I TOTAL PSA REAGENT KIT
Report
- Report Number
- 3008344661-2025-00004
- Event Type
- Malfunction
- Date Received
- January 13, 2025
- Date of Event
- December 24, 2024
- Report Date
- March 17, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MTF
- UDI-DI
- 00380740210557
- PMA / PMN Number
- N/A
- 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 07P92-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, WITH 510K/PMA/BLA NUMBER P910007. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
SECTION D4 - CATALOG #: THIS SECTION WAS CORRECTED FROM 07P92-30 TO 07P92-32. SECTION D4 - EXPIRATION DATE: THIS SECTION WAS CORRECTED FROM 30JUL2025 TO 03JUL2025. SECTION D4 - PRIMARY UDI NUMBER: THIS SECTION WAS CORRECTED FROM (B)(4). THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, AND A LABELING REVIEW. ADDITIONALLY, IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOTAL PSA 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 67226FZ00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 67226FZ00 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. IN ADDITION, IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE LOT 67226FZ00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TOTAL PSA REAGENT, LOT NUMBER 67226FZ00, WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT, WHICH WAS INCONSISTENT WITH THE PATIENT¿S HISTORICAL RESULTS. A NEW SAMPLE WAS DRAWN, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: = 4 NG/ML. INITIAL RESULT = 5 NG/ML; REPEAT RESULT = CONSISTENT WITH INITIAL RESULT (NO SPECIFIC VALUE PROVIDED). RESULT FROM NEW BLOOD DRAW = <1 NG/ML. HISTORICAL RESULTS = <1 NG/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT, WHICH WAS INCONSISTENT WITH THE PATIENT¿S HISTORICAL RESULTS. A NEW SAMPLE WAS DRAWN, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: = 4 NG/ML. INITIAL RESULT = 5 NG/ML; REPEAT RESULT = CONSISTENT WITH INITIAL RESULT (NO SPECIFIC VALUE PROVIDED) RESULT FROM NEW BLOOD DRAW = <1 NG/ML. HISTORICAL RESULTS = <1 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513085 | ALINITY I TOTAL PSA REAGENT KIT | TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER | MTF | ABBOTT IRELAND DIAGNOSTICS DIVISION | 67226FZ00 | 00380740210557 |
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) |