ALINIQ AMS
Report
- Report Number
- 3004032053-2025-00012
- Event Type
- Malfunction
- Date Received
- April 15, 2025
- Date of Event
- March 27, 2025
- Report Date
- May 7, 2025
- Manufacturer
- ABBOTT SRL
- Product Code
- JQP
- UDI-DI
- 00380740158255
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION FOR MISMATCH IN REFERENCE RANGES DUE TO A CONFIGURATION ERROR WHEN THE CS COAGULATION ANALYZER WAS ADDED TO THE ALINIQ AMS SOFTWARE INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, AND LABELING REVIEW. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO INCREASE IN COMPLAINT ACTIVITY. THE INVESTIGATION REVEALED THAT ON LABONLINELINK, THE QPL RULE FOR SENDING RESULTS TO THE LIS WAS INCORRECTLY CONFIGURED ON THE ACL ANALYZER, RESULTING IN THE WRONG MAPPING OF THE ANALYZER ID. THIS LED TO A MISMATCH IN THE REFERENCE RANGE. REVIEW OF THE QPL HISTORY INDICATED THAT THESE CHANGES WERE LIKELY MADE ON MARCH 21ST, WHEN NEW INSTRUMENTS WERE CONFIGURED TO REPLACE THE OLD ONES BY AN ABBOTT SERVICE REPRESENTATIVE. THE INCORRECT CONFIGURATION WITH THE OLD INSTRUMENTS WAS REMOVED FROM THE MIDDLEWARE, WHICH RESOLVED THE ISSUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF ALINIQ AMS SOFTWARE, VERSION 2.08, WAS IDENTIFIED.
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.
THE CUSTOMER OBSERVED A CONFIGURATION ERROR AFTER ADDING A NEW ANALYZER ON THE ALINIQ AMS. THE CUSTOMER REPORTED THAT THERE WAS A CONFIGURATION ERROR WHEN THE CS COAGULATION ANALYZER WAS ADDED TO THE AMS TO REPLACE THE ACL TOP COAGULATION ANALYZER. THE RESULTS FROM THE CS ANALYZER WERE SENT TO THE LIS INDICATING THEY WERE GENERATED ON THE ACL TOP AND, THEREFORE, A MISMATCH IN THE REFERENCE RANGES OCCURRED DUE TO THE DIFFERENCE IN PLATFORMS. THERE WERE NUMEROUS SAMPLES AFFECTED BY THIS SINCE (B)(6) 2025. THE CUSTOMER INDICATED THERE WAS NO DELAYED OR MISSED TREATMENT AND NO PHYSICIANS CONTACTED THE LABORATORY WITH CONCERNS ABOUT THE RESULTS REPORTED OUT. THE CUSTOMER NOTICED THE ISSUE IN THE LIS, CORRECTED IT MANUALLY IN THE LIS, AND NOTIFIED PHYSICIANS OF THE ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT DUE TO THE ISSUE.
THE CUSTOMER OBSERVED A CONFIGURATION ERROR AFTER ADDING A NEW ANALYZER ON THE ALINIQ AMS. THE CUSTOMER REPORTED THAT THERE WAS A CONFIGURATION ERROR WHEN THE CS COAGULATION ANALYZER WAS ADDED TO THE AMS TO REPLACE THE ACL TOP COAGULATION ANALYZER. THE RESULTS FROM THE CS ANALYZER WERE SENT TO THE LIS INDICATING THEY WERE GENERATED ON THE ACL TOP AND, THEREFORE, A MISMATCH IN THE REFERENCE RANGES OCCURRED DUE TO THE DIFFERENCE IN PLATFORMS. THERE WERE NUMEROUS SAMPLES AFFECTED BY THIS SINCE (B)(6) 2025. THE CUSTOMER INDICATED THERE WAS NO DELAYED OR MISSED TREATMENT AND NO PHYSICIANS CONTACTED THE LABORATORY WITH CONCERNS ABOUT THE RESULTS REPORTED OUT. THE CUSTOMER NOTICED THE ISSUE IN THE LIS, CORRECTED IT MANUALLY IN THE LIS, AND NOTIFIED PHYSICIANS OF THE ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT DUE TO THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109497 | ALINIQ AMS | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE | JQP | ABBOTT SRL | 00380740158255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |