MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I REAGENT KIT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	02K41-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that false positive architect stat troponin-i results were generated for two patients.The following data was provided.Patient 1: date of testing not provided.Initial result: 0.240 ng/ml (positive) repeat result: 0.008 ng/ml (negative) patient 2: (b)(6) 2023 initial result: 0.03 ng/ml (positive).Repeat results: 0.009 and 0.005 ng/ml (negative).Normal range: 0.0 - 0.027 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Device history record review did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Historical performance of reagent lot 56561un23 was evaluated using worldwide data for the troponin-i assay and determined that patient median result for the lot is comparable with other lots in the field and within established baselines confirming no systemic issue for the lot.Based on the investigation, no deficiency for architect stat troponin-i reagent lot 56561un23 was identified.
Event or Problem Description
The customer stated that false positive architect stat troponin-i results were generated for two patients.The following data was provided.Patient 1.Date of testing not provided.Initial result: 0.240 ng/ml (positive).Repeat result: 0.008 ng/ml (negative).Patient 2.(b)(6) 2023.Initial result: 0.03 ng/ml (positive).Repeat results: 0.009 and 0.005 ng/ml (negative).Normal range: 0.0 - 0.027 ng/ml.No impact to patient management was reported.

• Brand Name: ARCHITECT STAT TROPONIN-I REAGENT KIT
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17995682
• Report Number: 1415939-2023-00057
• Device Sequence Number: 5957342
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: 00380740048525
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 02K41-27
• Device Lot Number: 56561UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR INTGR, 01L86-40, I1SR65023; ARC I1000SR INTGR, 01L86-40, I1SR65023
• Patient Sex: Unknown