ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
Report
- Report Number
- 3005094123-2026-00081
- Event Type
- Malfunction
- Date Received
- February 18, 2026
- Date of Event
- February 7, 2026
- Report Date
- April 15, 2026
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MMI
- UDI-DI
- 00380740160630
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT, LOT 81020UD00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. REVIEW OF TRACKING AND TRENDING DATA FOR LOT 81020UD00 DID IDENTIFY AN INCREASE IN COMPLAINTS, HOWEVER, THE SEARCH BY LIST NUMBER DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE CURRENT COMPLAINT ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT, LOT 81020UD00.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13-24 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21, WITH 510K NUMBER K202525. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 75-YEAR-OLD FEMALE PATIENT WHO ARRIVED WITH MILD CHEST PAIN, PALPITATIONS AND HYPERTENSION. THE CUSTOMER BELIEVES THAT THE RESULT SHOULD BE NEGATIVE AFTER OBTAINING AN ECG AND OTHER TESTING. THE PATIENT WAS GIVEN TREATMENT, BUT THE TYPE OF TREATMENT IS UNKNOWN. THE PATIENT WAS DISCHARGED AND IS DOING WELL. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE < 0.015 NG/ML): ON (B)(6) 2026 (12:58) SID (B)(6) INITIAL RESULT 0.0243 NG/ML, REPEATED AT (18:27) <0.0100 NG/ML. A NEW SAMPLE WAS OBTAINED SID (B)(6) RESULT <0.0100 NG/ML (17:58). A NEW SAMPLE WAS OBTAINED (B)(6) 2026 SID (B)(6) 0.0308 NG/ML (00:42); REPEATED ON 09FEB2026 AT (10:46) <0.0100 NG/ML. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 75-YEAR-OLD FEMALE PATIENT WHO ARRIVED WITH MILD CHEST PAIN, PALPITATIONS AND HYPERTENSION. THE CUSTOMER BELIEVES THAT THE RESULT SHOULD BE NEGATIVE AFTER OBTAINING AN ECG AND OTHER TESTING. THE PATIENT WAS GIVEN TREATMENT, BUT THE TYPE OF TREATMENT IS UNKNOWN. THE PATIENT WAS DISCHARGED AND IS DOING WELL. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE < 0.015 NG/ML): ON (B)(6) 2026 (12:58) SID (B)(6) INITIAL RESULT 0.0243 NG/ML, REPEATED AT (18:27) <0.0100 NG/ML A NEW SAMPLE WAS OBTAINED SID (B)(6) RESULT <0.0100 NG/ML (17:58). A NEW SAMPLE WAS OBTAINED (B)(6) 2026 SID (B)(6) 0.0308 NG/ML (00:42); REPEATED ON (B)(6) 2026 AT (10:46) <0.0100 NG/ML. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129664 | ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ABBOTT IRELAND DIAGNOSTICS DIVISION | 81020UD00 | 00380740160630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6) |