MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT STAT HIGH SENSITIVE TROPONIN-I; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 03P25-74

Device Problem Low Test Results (2458)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect stat high sensitive troponin-i, list number 03p25-74, that has a similar product distributed in the us, list number 02r98.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

A literature article by (b)(6), et al., ¿evaluation of the analytical and clinical performance of a new high-sensitivity cardiac troponin i assay: hs-ctni (clia) assay¿, clinical chemistry and laboratory medicine (b)(6) 2023, documented false negative architect stat high sensitive troponin-i results for 9 patient samples.The article documented a study that noted false negative architect stat high sensitive troponin-i results generated for 9 patient samples.Five out of nine samples were from confirmed ami (acute myocardial infarction) patients who tested negative with architect stat high sensitive troponin-i.The same five samples were also negative with the mindray; however, two of the five samples tested positive with the backman access.The article noted that these patients presented early after the onset of symptoms which might show no elevation of troponin levels.Four out of 9 patient samples with false negative architect stat high sensitive troponin-i were also noted during the interference study which included specimens with high probability of interference including ana (antinuclear antibodies), rf (rheumatoid factors) positive, samples from patients with systemic lupus erythematosus and renal dialysis.The article did not provide any specific results.Patients with architect stat high sensitive troponin-i value above sex-specific 99th percentile urls (upper reference limits) were regarded as positive (morethan 34.2 ng/l for male or more than 15.6 ng/l for female).No impact to patient management was reported.

Event Description

A literature article by li ling, et al., ¿evaluation of the analytical and clinical performance of a new high-sensitivity cardiac troponin i assay: hs-ctni (clia) assay¿, clinical chemistry and laboratory medicine (b)(6) 2023), documented false negative architect stat high sensitive troponin-i results for 9 patient samples.The article documented a study that noted false negative architect stat high sensitive troponin-i results generated for 9 patient samples.Five out of nine samples were from confirmed ami (acute myocardial infarction) patients who tested negative with architect stat high sensitive troponin-i.The same five samples were also negative with the mindray; however, two of the five samples tested positive with the backman access.The article noted that these patients presented early after the onset of symptoms which might show no elevation of troponin levels.Four out of 9 patient samples with false negative architect stat high sensitive troponin-i were also noted during the interference study which included specimens with high probability of interference including ana (antinuclear antibodies), rf (rheumatoid factors) positive, samples from patients with systemic lupus erythematosus and renal dialysis.The article did not provide any specific results.Patients with architect stat high sensitive troponin-i value above sex-specific 99th percentile urls (upper reference limits) were regarded as positive (>34.2 ng/l for male or >15.6 ng/l for female).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely negative architect stat high sensitive troponin-i results included a review of data and information from the article ¿evaluation of the analytical and clinical performance of a new high-sensitivity cardiac troponin i assay: hs-ctni (clia) assay¿, ticket trending review, device history record review, field data review and labeling review.Return testing was not completed as returns were not available.Data and information provided in the article were reviewed and support the complaint issue.Ticket trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 03p25 and complaint issue.The overall performance of the architect stat high sensitive troponin-i assay was reviewed using field data from customers worldwide.All in-date lots with at least 10,000 patient results show that all median values are within established limits and comparable with historical lots in the field, confirming no systemic issue for the lots.Labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect stat high sensitive troponin-i, reagent lot unknown.

• Brand Name: ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17958768
• MDR Text Key: 326126276
• Report Number: 3005094123-2023-00277
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K191595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

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: 03P25-74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/24/2023
• 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, 116UNKNOWND14; ARC I2000SR INST, 03M74-02, 116UNKNOWND14