ALINITY I TOTAL PSA REAGENT KIT
Report
- Report Number
- 3008344661-2025-00107
- Event Type
- Malfunction
- Date Received
- August 6, 2025
- Date of Event
- February 4, 2025
- Report Date
- September 22, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MTF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P92-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21/-31, WITH 510K/PMA/BLA NUMBER P910007.
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 IN-HOUSE TESTING WAS COMPLETED USING A RETAINED KIT OF THE COMPLAINT LOT. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. 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 69265FZ00. PERFORMANCE TESTING WAS COMPLETED USING AN IN-HOUSE RETAIN KIT OF COMPLAINT LOT 69265FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I TOTAL PSA REAGENT LOT 69265FZ00 WAS IDENTIFIED.
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT FOR A 101-YEAR-OLD PATIENT GENERATED USING REAGENT LOT 69265FZ00 ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE USED: UG/L): SAMPLE ID (B)(6): (B)(6) 2024 PSA 0.8 - ALINITY. (B)(6) 2024 PSA 4.4 - ALINITY. (B)(6) 2025 PSA 8.1 ¿ ALINITY (QUESTIONED RESULT). (B)(6) 2025 PSA 4.1 ¿ ROCHE. CUSTOMER¿S REFERENCE RANGE FOR TOTAL PSA: >/= 70 YRS: < 6.6 UG/L. THE CUSTOMER STATED THE QC WAS WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT FOR A 101-YEAR-OLD PATIENT GENERATED USING REAGENT LOT 69265FZ00 ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE USED: UG/L): SAMPLE ID (B)(6): (B)(6) 2024 PSA 0.8 - ALINITY. (B)(6) 2024 PSA 4.4 - ALINITY. (B)(6) 2025 PSA 8.1 ¿ ALINITY (QUESTIONED RESULT). (B)(6) 2025 PSA 4.1 ¿ ROCHE. CUSTOMER¿S REFERENCE RANGE FOR TOTAL PSA: >/= 70 YRS: < 6.6 UG/L. THE CUSTOMER STATED THE QC WAS WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1528417 | ALINITY I TOTAL PSA REAGENT KIT | TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER | MTF | ABBOTT IRELAND DIAGNOSTICS DIVISION | 69265FZ00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 101 YR | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6). |