MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 03P25-26

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

A provided literature article by bruinen, anne l.Et al., ¿point-of-care high-sensitivity troponin-i analysis in capillary blood for acute coronary syndrome diagnostics¿, clinical chemistry and laboratory medicine 60.10: 1669-1674.De gruyter open ltd.(sep 1, 2022), documented a validation study for the atellica® vtli patient-side immunoassay analyzer for high-sensitivity poc cardiac troponin-i (hs-ctni) and compared test results to on architect troponin-i, stat high sensitive and the roche method.The study documented two incidents of false negative architect troponin-i, stat high sensitive results for patient 1 and patient 2 when compared to the roche method and the poc method.Patient 1 was an 88-year-old female with chest pain and slight rise of architect troponin-i, stat high sensitive results.Pulmonary emboli and aortic dissection were ruled out.The roche troponin-t concentration rose to 34 ng/l the next day, but the patient did not have any complaints.Oral antianginal drugs were prescribed, she was discharged and a spect scan at the outpatient clinic showed non-significant perfusion defects and no signs of left ventricle dysfunction.Architect troponin-i, stat high sensitive result was 22.6 ng/l (cutoff 26.2 ng/l), roche result was 23 ng/l (cutoff 14 ng/l), atellica vtli poc result was 24.3 ng/l (cutoff 22.9 ng/l).Patient 2 was a 65-year-old female patient presenting to the ed with typical chest pain.Acs was ruled out based on the roche results.Architect troponin-i, stat high sensitive result was <2.0 ng/l (cutoff 26.2 ng/l), roche result was 6 ng/l (cutoff 14 ng/l), atellica vtli poc result was 110.9 ng/l (cutoff 22.9 ng/l).No adverse impact to patient management was reported.

Manufacturer Narrative

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 03p25 that has a similar product distributed in the us, list number 02r98.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Return testing was not performed as returns were not available.The ticket trending review did not identify any trend regarding commonalities for lot numbers and issue.Labeling was reviewed which adequately addresses the current issue.Customer field data was used to assess the performance of the architect stat high sensitive troponin-i assay using worldwide data through abbottlink.Review shows that the median patient result for the lots (reviewed with at least 10,000 data points) is within established limits and comparable with other lots in the field, confirming no systemic issue for the lots.Based on the investigation, no systemic issue or deficiency of the architect stat high sensitive troponin-i assay was identified.

• Brand Name: ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15639790
• MDR Text Key: 303237369
• Report Number: 3005094123-2022-00227
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K191595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P25-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, 116UNKNOWN11.; ARC I2000SR INST, 03M74-02, 116UNKNOWN11.