ALINITY I PROCESSING MODULE
Report
- Report Number
- 3016438761-2025-00209
- Event Type
- Malfunction
- Date Received
- April 7, 2025
- Date of Event
- March 26, 2025
- Report Date
- April 24, 2025
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JJE
- UDI-DI
- 00380740137366
- PMA / PMN Number
- K170317
- 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 FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03R65, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K170317.
ADDITIONAL INFORMATION IN SECTION D10 - CONCOMITANT PRODUCT AND SECTION H4 - DEVICE MFG DATE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND PERFORMED MULTIPLE TROUBLE SHOOTING PROCEDURES. THE FSR FOUND PARTICLES/SEDIMENT IN THE BASE OF THE TRIGGER BOTTLE REF THE BULK SOLUTIONS, WHICH WAS CLEANED AND REFILLED. ADDITIONALLY, THE PUMP, BULK SOLUTION TRANSFER WAS REPLACED. THE PUMP, BULK SOLUTION TRANSFER WAS DEEMED THE LIKELY CAUSE FOR THE FALSE ELEVATED RESULT. THE MODULE FUNCTION WAS VERIFIED WITH A CONTROL RUN. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE PUMP, BULK SOLUTION TRANSFER DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I PROCESSING MODULE FOR SERIAL (B)(6) OR THE PUMP, BULK SOLUTION TRANSFER WERE IDENTIFIED.
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.0-19.0 PMOL/L): (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = 24.7 PMOL/L, (B)(6) 2025 REPEAT RESULT = 13.7 PMOL/L, REPEAT RESULT ON ANOTHER ANALYZER (B)(6) = 13.86 PMOL/L. ADDITIONAL RESULTS PROVIDED: FSH RESULT = 4.641 IU/L. TSH RESULT = 0.757 MIU/L. SHBG RESULT = 51.12 NMOL/L. LH RESULT = 3.227 IU/L. TESTO RESULT = <0.450 NMOL/L, (B)(6) 2025 REPEAT RESULT = 0.477 NMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.0-19.0 PMOL/L): (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = 24.7 PMOL/L, (B)(6) 2025 REPEAT RESULT = 13.7 PMOL/L, REPEAT RESULT ON ANOTHER ANALYZER (B)(6) = 13.86 PMOL/L. ADDITIONAL RESULTS PROVIDED: FSH RESULT = 4.641 IU/L. TSH RESULT = 0.757 MIU/L. SHBG RESULT = 51.12 NMOL/L. LH RESULT = 3.227 IU/L. TESTO RESULT = <0.450 NMOL/L, (B)(6) 2025 REPEAT RESULT = 0.477 NMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1459256 | ALINITY I PROCESSING MODULE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | ABBOTT LABORATORIES | 00380740137366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY I FREE T4 1200T, 07P70-30, 70400UD00| ALNTY I FREE T4 1200T, 07P70-30, 70400UD00| PUMP, BULK SOLUTION TRANSFER, A-30111949-01, UNKNO |