ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
Report
- Report Number
- 3005094123-2024-00499
- Event Type
- Malfunction
- Date Received
- September 26, 2024
- Date of Event
- September 10, 2024
- Report Date
- November 3, 2024
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MMI
- UDI-DI
- 00380740164157
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT IS PERFORMING AS EXPECTED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER 64553UD01 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE MEDIAN PATIENT RESULT FOR LOT 64553UD01 IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE WITH HISTORICAL LOTS IN THE FIELD. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I, REAGENT LOT 64553UD01 WAS IDENTIFIED.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY I STAT HIGH SENSITIVE TROPONIN-I, LIST NUMBER 08P13-77, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 10-DAY-OLD PATIENT. IT WAS NOTED THAT THE PATIENT AND THE PATIENT¿S MOTHER DO NOT HAVE ANY HEART-RELATED DISEASES AND BOTH TESTED NEGATIVE FOR AUTOANTIBODIES. THE CUSTOMER PERFORMED A DOUBLE DILUTION AND 25% PEG PRECIPITATION WHICH GENERATED NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: <241 PG/ML. ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT = 6000 PG/ML. DOUBLE DILUTION = SHOWED THE RESULTS WERE NOT LINEAR. 25% PEG PRECIPITATION: RESULT = 60 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 10-DAY-OLD PATIENT. IT WAS NOTED THAT THE PATIENT AND THE PATIENT¿S MOTHER DO NOT HAVE ANY HEART-RELATED DISEASES AND BOTH TESTED NEGATIVE FOR AUTOANTIBODIES. THE CUSTOMER PERFORMED A DOUBLE DILUTION AND 25% PEG PRECIPITATION WHICH GENERATED NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: <241 PG/ML. ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT = 6000 PG/ML. DOUBLE DILUTION = SHOWED THE RESULTS WERE NOT LINEAR. 25% PEG PRECIPITATION: RESULT = 60 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1166264 | ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ABBOTT IRELAND DIAGNOSTICS DIVISION | 64553UD01 | 00380740164157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 DA | Unknown | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |