FDA Adverse Event Malfunction Summary report: N

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

MDR report key: 24778969 · Received April 3, 2026

Report

Report Number: 3005094123-2026-00162
Event Type: Malfunction
Date Received: April 3, 2026
Date of Event: March 26, 2026
Report Date: April 3, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: MMI
UDI-DI: 00380740118075
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TH
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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98 (TROPONIN-I STAT HIGH SENSITIVITY), WITH 510K/PMA/BLA NUMBER K191595.

Description of Event or Problem · 0

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ARCHITECT I1000SR ANALYZER FOR A 71-YEAR-OLD FEMALE PATIENT PRESENTED WITH CHEST PAIN (UNSPECIFIED) AND ABDOMINAL PAIN (UNSPECIFIED). THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, SID (B)(6): INITIAL 0-HOUR RESULT = 41.81 NG/L (FEMALE REFERENCE RANGE: < 15.6 NG/L) REPEAT 1-HOUR RESULT = < 1.9 NG/L REPEATED 0-HOUR SAMPLE AFTER RE-CENTRIFUGATION RESULT = < 1.9 NG/L THE 0-HOUR SAMPLE WAS TESTED IN 5 REPLICATES AND ALL RESULTS GENERATED < 1.9 NG/L EACH TIME. INTERNAL QC: ALL LEVELS PASSED AND WITHIN ACCEPTABLE RANGES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
840581	ARCHITECT STAT HIGH SENSITIVE TROPONIN-I	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	MMI	ABBOTT IRELAND DIAGNOSTICS DIVISION		82347UD00	00380740118075

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR	Female		ARC I1000SR INTGR, 01L86-40, (B)(6)