ALINITY I FREE PSA REAGENT KIT
Report
- Report Number
- 3008344661-2025-00014
- Event Type
- Malfunction
- Date Received
- February 10, 2025
- Date of Event
- January 17, 2025
- Report Date
- May 1, 2025
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MTG
- UDI-DI
- 00380740130329
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P93-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P93-21/31, WITH 510K/PMA/BLA NUMBER P980007. 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 IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 65532FZ00. 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. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE PSA REAGENT LOT 65532FZ00 WAS IDENTIFIED.
THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I FREE PSA AND PROVIDED THE FOLLOWING DATA FOR A MALE PATIENT WITH A HISTORY OF PROSTATIC HYPERPLASIA, PRESENTING WITH URINARY TRACT INFECTION AND HEMATURIA. SAMPLE ID (B)(6) WAS DRAWN ON (B)(6) 2025: ON THE BECKMAN PLATFORM THE FREE PSA WAS >19.00. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 AND THE FREE PSA WAS 0.07. A SECOND SAMPLE (SAMPLE ID (B)(6) WAS DRAWN ON (B)(6)2025: ON THE BECKMAN PLATFORM THE FREE PSA WAS 5.359. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 AND THE FREE PSA WAS 6.528. PATIENT HISTORICAL VALUES: ON (B)(6) 2024, FREE PSA WAS 1.891 (PLATFORM UNKNOWN). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I FREE PSA AND PROVIDED THE FOLLOWING DATA FOR A MALE PATIENT WITH A HISTORY OF PROSTATIC HYPERPLASIA, PRESENTING WITH URINARY TRACT INFECTION AND HEMATURIA. SAMPLE ID (B)(6) WAS DRAWN ON (B)(6) 2025: ON THE BECKMAN PLATFORM THE FREE PSA WAS >19.00. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 AND THE FREE PSA WAS 0.07 A SECOND SAMPLE (SAMPLE ID (B)(6)) WAS DRAWN ON (B)(6) 2025: ON THE BECKMAN PLATFORM THE FREE PSA WAS 5.359. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 AND THE FREE PSA WAS 6.528. PATIENT HISTORICAL VALUES: ON (B)(6) 2024, FREE PSA WAS 1.891 (PLATFORM UNKNOWN). 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 |
|---|---|---|---|---|---|---|---|
| 959268 | ALINITY I FREE PSA REAGENT KIT | TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER | MTG | ABBOTT IRELAND DIAGNOSTICS DIVISION | 65532FZ00 | 00380740130329 |
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) |