FDA Adverse Event Malfunction Summary report: N

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

MDR report key: 24462219 · Received February 26, 2026

Report

Report Number: 3005094123-2026-00099
Event Type: Malfunction
Date Received: February 26, 2026
Date of Event: February 16, 2026
Report Date: April 29, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: MMI
UDI-DI: 00380740118075
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
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. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 3P25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 2R98, AND A 510K/PMA/BLA NUMBER: K191595.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGHLY SENSITIVE TROPONIN-I RESULTS GENERATED FOR A MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE FOR MALES 34.2 PG/ML): ON (B)(6) 2026, SAMPLE ID: (B)(6) INITIAL RESULT = 44.9 PG/ML, REPEAT RESULTS = 4 PG/ML, 4.3 PG/ML. SAME PATIENT NEW SAMPLE OBTAINED. SAMPLE ID: (B)(6) RESULT = 4.7 PG/ML, REPEAT RESULT = 4 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
85859	ARCHITECT STAT HIGH SENSITIVE TROPONIN-I	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	MMI	ABBOTT IRELAND DIAGNOSTICS DIVISION		80401UD00	00380740118075

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male		ARC I1000SR MOD, 01L86-01, I1SR01771\| ARC I1000SR MOD, 01L86-01, I1SR01771