ALINITY C PROCESSING MODULE
Report
- Report Number
- 3016438761-2025-00303
- Event Type
- Malfunction
- Date Received
- May 22, 2025
- Date of Event
- May 8, 2025
- Report Date
- June 25, 2025
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JJE
- UDI-DI
- 00380740137380
- PMA / PMN Number
- K170316
- 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. SECTION A1 SID ADDED ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
DURING THE SUBSEQUENT SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER WAS INSPECTED, AND VARIOUS DIAGNOSTIC CHECKS OF THE SYSTEM, AND REPLACING PARTS (WASH CUP, REAGENT PROBES AND A NOZZLE). A REVIEW OF THE ANALYZER SERVICE HISTORY AND LOGS IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE SITE VISIT BY THE FSE. THE ALINITY SYSTEMS OPERATIONS MANUAL ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC RESULTS. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE CLINICAL CHEMISTRY PLATFORMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCIES WERE IDENTIFIED.
THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 105 / 139 MMOL/L, (REFERENCE RANGE: 133-146 MMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: 105 / 139 MMOL/L, (REFERENCE RANGE: 133-146 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 105 / 139 MMOL/L, (REFERENCE RANGE: 133-146 MMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1220526 | ALINITY C PROCESSING MODULE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | ABBOTT LABORATORIES | 00380740137380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ALNTY C ICT SAMPLE DILU, 07P53-20, 77016UN24| ALNTY C ICT SAMPLE DILU, 07P53-20, 77016UN24| ALNTY C ICT SAMPLE DILU, 07P53-20, 77016UN24 |