FDA Adverse Event
Malfunction
Summary report: N
ALINITY I STAT HIGH SENSITIVITY TROPONIN-I
MDR report key: 25232520
·
Received May 20, 2026
Report
- Report Number
- 3005094123-2026-00239
- Event Type
- Malfunction
- Date Received
- May 20, 2026
- Date of Event
- April 25, 2026
- Report Date
- May 20, 2026
- Manufacturer
- ABBOTT IRELAND DIAGNOSTICS DIVISION
- Product Code
- MMI
- UDI-DI
- 00380740194062
- PMA / PMN Number
- K202525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem · 0
THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I HIGH SENSITIVE TROPONIN RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 39-YEAR-OLD MALE PATIENT. SID (B)(6) INITIAL RESULT = 87.75 NG/L. A NEW SAMPLE, SID (B)(6), WAS DRAWN GENERATING A RESULT <2.70 NG/L. BOTH SAMPLES WERE REPEATED AND GENERATED A RESULT OF <2.70 NG/L. THE CUSTOMER¿S REFERENCE RANGE IS 0-53 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560109 | ALINITY I STAT HIGH SENSITIVITY TROPONIN-I | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ABBOTT IRELAND DIAGNOSTICS DIVISION | 85393UD00 | 00380740194062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male | ALNTY I PROCESSING MODU, 03R65-01, AI25780. |