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

Catalog Number 03P25-77

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available. phone complete entry: (b)(6).This report is being filed on an international product, list number 03p25 has a similar product distributed in the us, list number 2r98.

Event Description

The customer observed a falsely elevated architect stat high sensitive troponin-i results for a patient that is hospitalized.The following data was provided (customer¿s reference range- < 0.028 ng/ml = negative): (b)(6) 2022 initial result : sample 1 = 1.9908, repeat result =1.095 ng/ml.Initial result sample 2 (same patient, new sample) = 0.0027, repeat result = 0.0026 ng/ml no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for imprecise/discrepant architect stat high sensitive troponin-i results included a review of data and information provided by the customer, a search for similar complaints, ticket trending review, labeling, device history records, and in house testing of a retained reagent kit.Return testing was not completed as returns were not available.A review shows that the median patient result for lot 41404ud01 was within established limits and comparable with other lots in the field, confirming no systemic issue for the lots.Trending review determined no related trend for the issue for the product.Device history record review on lot 41404ud01 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.An in-house retained reagent kit of the complaint lot was tested, and all specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect stat high sensitive troponin-i for lot number 41404ud01 was identified.Corrected information in b5 and h6 medical device problem code.

Event Description

The customer observed discrepant architect stat high sensitive troponin-i results for a patient that is hospitalized.The following data was provided (customer¿s reference range- < 0.028 ng/ml = negative): 01oct2022 initial result sample 1 = 1.9908, repeat result =1.095 ng/ml initial result sample 2 (same patient, new sample) = 0.0027, repeat result = 0.0026 ng/ml no impact to patient management was reported.

• 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: 15569362
• MDR Text Key: 303157030
• Report Number: 3005094123-2022-00219
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/13/2022

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 Expiration Date: 12/07/2022
• Device Catalogue Number: 03P25-77
• Device Lot Number: 41404UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 11/24/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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, ISR60084; ARC I2000SR INST, 03M74-02, ISR60084