ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

Report

Report Number: 3005094123-2026-00096
Event Type: Malfunction
Date Received: February 25, 2026
Date of Event: January 30, 2026
Report Date: April 30, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: MMI
UDI-DI: 00380740160647
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
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. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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.

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION ADDED TO SECTION B5 DESCRIBE EVENT OR PROBLEM. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem · 0

DURING A CORRELATION STUDY, THE CUSTOMER OBSERVED ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR THREE PATIENTS WHEN COMPARED TO OTHER METHODS (ROCHE AND AFIAS). THE ALINITY RESULTS HAD BEEN PREVIOUSLY REPORTED AND ARCHIVED. FOR THIS STUDY, THE ARCHIVED SAMPLES WERE TESTED USING THE SERVIBIO AFIAS (POINT-OF-CARE TESTING) TECHNIQUE AND ROCHE ELECSYS TROPONIN. THE FOLLOWING DATA WAS PROVIDED: 84-YEAR-OLD MALE, SID (B)(6), PATIENT BACKGROUND: ADMITTED TO EMERGENCY DEPARTMENT FOR RHABDOMYOLYSIS, HISTORY OF COMPLETE ARRHYTHMIA WITH ATRIAL FIBRILLATION (AF) AND BUNDLE BRANCH BLOCK. ALINITY (SN (B)(6)) (B)(6) 2026 41.6 AND 45.5 NG/L (CUTOFF <6NG/L). ROCHE ELECSYS (B)(6) 2026 <100 NG/L (CUTOFF <100 NG/L). AFIAS SERVBIO (B)(6) 2026 26 NG/L (CUTOFF <30 NG/L). 75-YEAR-OLD FEMALE, SID (B)(6), PATIENT BACKGROUND: DIALYSIS, TROPONIN LEVELS REQUESTED. . FOLLOWING VOMITING AND CHEST PAIN, ELECTRO-CARDIOVERSION. ALINITY (SN (B)(6)) (B)(6) 2026 54.5 / 50.9 / 41.7 / 41.9 NG/L. ALINITY (SN (B)(6)) (B)(6) 2026 42.6 / 42.1 NG/L. ALINITY (SN (B)(6)) (B)(6) 2026 68 NG/L. ROCHE ELECSYS (B)(6) 2026 <100 NG/L. AFIAS SERVBIO (B)(6) 2026 28 / 38 / 31 NG/L. 54-YEAR-OLD MALE, SID (B)(6), PATIENT BACKGROUND: ADMITTED TO THE EMERGENCY ROOM FOR CHEST PAIN, CORONARY ANGIOGRAPHY, GASTRIC REFLUX, ARTERIAL HYPERTENSION (HYPERTENSION AT 17/18 CMHG) ASSOCIATED WITH OVERWEIGHT, PERICARDIUM INFLAMMATION, CARDIAC MRI. ALINITY (SN (B)(6)) (B)(6) 2026 81.6 / 84.5 NG/L. AFIAS SERVBIO 12 NG/L. ROCHE ELECSYS <100 NG/L NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem · 0

DURING A CORRELATION STUDY, THE CUSTOMER OBSERVED ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR THREE PATIENTS WHEN COMPARED TO OTHER METHODS (ROCHE AND AFIAS). THE ALINITY RESULTS HAD BEEN PREVIOUSLY REPORTED AND ARCHIVED. FOR THIS STUDY, THE ARCHIVED SAMPLES WERE TESTED USING THE SERVIBIO AFIAS (POINT-OF-CARE TESTING) TECHNIQUE AND ROCHE ELECSYS TROPONIN. THE FOLLOWING DATA WAS PROVIDED: 84-YEAR-OLD MALE, SID: (B)(6), PATIENT BACKGROUND: ADMITTED TO EMERGENCY DEPARTMENT FOR RHABDOMYOLYSIS, HISTORY OF COMPLETE ARRHYTHMIA WITH ATRIAL FIBRILLATION (AF) AND BUNDLE BRANCH BLOCK. ALINITY (SN: (B)(6) ON (B)(6) 2026 41.6 AND 45.5 NG/L (CUTOFF <6NG/L). ROCHE ELECSYS ON (B)(6) 2026 <100 NG/L (CUTOFF <100 NG/L). AFIAS SERVBIO ON (B)(6) 2026 26 NG/L (CUTOFF <30 NG/L). 75-YEAR-OLD FEMALE, SID: (B)(6), PATIENT BACKGROUND: DIALYSIS, TROPONIN LEVELS REQUESTED FOLLOWING VOMITING AND CHEST PAIN, ELECTRO-CARDIOVERSION. ALINITY (SN: (B)(6) ON (B)(6) 2026 54.5 / 50.9 / 41.7 / 41.9 NG/L. ALINITY (SN: (B)(6) ON (B)(6) 2026 42.6 / 42.1 NG/L. ALINITY (SN: (B)(6) ON (B)(6) 2026 68 NG/L. ROCHE ELECSYS ON (B)(6) 2026 <100 NG/L. AFIAS SERVBIO ON (B)(6) 2026 28 / 38 / 31 NG/L. 54-YEAR-OLD MALE, SID: (B)(6), PATIENT BACKGROUND: ADMITTED TO THE EMERGENCY ROOM FOR CHEST PAIN, CORONARY ANGIOGRAPHY, GASTRIC REFLUX, ARTERIAL HYPERTENSION (HYPERTENSION AT 17/18 CMHG) ASSOCIATED WITH OVERWEIGHT, PERICARDIUM INFLAMMATION, CARDIAC MRI. ALINITY (SN: (B)(6) ON (B)(6) 2026 81.6 / 84.5 NG/L. AFIAS SERVBIO 12 NG/L. ROCHE ELECSYS <100 NG/L. UPDATE: THE CUSTOMER PROVIDED ADDITIONAL RESULTS FROM THE CORRELATION STUDY. (ALINITY CUTOFF <6 NG/L. AFIAS CUTOFF 0.03 NG/ML. COBAS CUTOFF <0.10 NG/ML). SID: (B)(6) ALINITY RESULT 63.4 NG/L RERUN 62.4 NG/L, AFIAS RESULT 0.02 NG/ML. SID: (B)(6) ALINITY RESULT 49 NG/L RERUN 46.7 NG/L, AFIAS RESULT 0.027 NG/ML, COBAS RESULT <0.10 NG/ML. SID: (B)(6) ALINITY RESULT 20.5 NG/L RERUN 21.1 NG/L, AFIAS RESULT 0.018 NG/ML, COBAS RESULT <0.10 NG/ML. SID: (B)(6) ALINITY RESULT 38.1 NG/L RERUN 33.6 NG/L, AFIAS RESULT < 0.010 NG/ML, COBAS RESULT <0.10 NG/ML. SID: (B)(6) ALINITY RESULT 23.8 NG/L RERUN 21 NG/L, AFIAS RESULT 0.019 NG/ML, COBAS RESULT < 0.10 NG/ML. SID: (B)(6) ALINITY RESULT 32.3 NG/L, AFIAS RESULT 0.016 NG/ML, COBAS RESULT < 0.10 NG/ML. SID: (B)(6) ALINITY RESULT 29.3 NG/L RERUN 30.6 NG/L, AFIAS 0.018 NG/ML, COBAS RESULT < 0.10 NG/ML. SID: (B)(6) ALINITY RESULT 20.4 NG/L RERUN 18.3 NG/L, AFIAS RESULT < 0.010 NG/ML, COBAS RESULT < 0.10 NG/ML. SID: (B)(6) ALINITY RESULT 21.7 NG/L RERUN 20.5 NG/L, AFIAS RESULT 0.012 NG/ML, COBAS RESULT < 0.10 NG/ML. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
504452	ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	MMI	ABBOTT IRELAND DIAGNOSTICS DIVISION		81566UD00	00380740160647

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		ALNTY I PROCESSING MODU, 03R65-01, (B)(6).\| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).\| ALNTY I PROCESSING MODU,03R65-01, (B)(6).\| ALNTY I PROCESSING MODU,03R65-01, (B)(6).