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

Catalog Number	02R98-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated architect stat high sensitive troponin-i result on a 68-yr old female patient who presented to the emergency room with chest pain.The following results were provided: sid (b)(6) ¿ (b)(6) 2023 13:35 = 388 ng/l, repeated same sample at 19:26 = < 4 ng/l.Subsequent draws: sid - date/time collected result (b)(6) ¿ (b)(6) 2023 14:35, 4 ng/l.(b)(6) ¿ (b)(6) 2023 15:40 , 4 ng/l.Normal reference range: female <18 ng/l the patient had an abnormal ecg t-wave.Patient was administered the following: aspirin, plavix, heparin drip for management of acs.The patient was discharged on (b)(6) 2023 with a discharge condition of: good.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.Section a1 patient identifier sids: (b)(6).
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labelling, and device history records.Returns were not available.The review of historical performance of reagent lot 53390ud00, was completed.Trending review determined no trends for the issue for the product.Device history record review on lot 53390ud00 did not show any potential non-conformances, or deviations.Historical performance in the field using worldwide data was reviewed and determined that the patient median result for the lot is comparable with other lots in the field.Also, accuracy of the assay has been evaluated with a retained in-house kit of the same lot# 53390ud00 and met all specifications, confirming that this lot is meeting the architect stat high sensitive troponin-i product requirements.Labelling was reviewed and found to adequately address the issue under review.Based on the investigation, the architect stat high sensitive troponin-i lot number 53390ud00 identified no systemic issue and/or product deficiency.
Event or Problem Description
The customer reported a falsely elevated architect stat high sensitive troponin-i result on a 68-yr old female patient who presented to the emergency room with chest pain.The following results were provided: sid (b)(6) ¿ (b)(6) 2023 13:35 = 388 ng/l, repeated same sample at 19:26 = < 4 ng/l subsequent draws: sid - date/time collected result (b)(6) ¿ (b)(6) 2023 14:35 4 ng/l (b)(6) ¿ (b)(6) 2023 15:40 4 ng/l normal reference range: female <18 ng/l the patient had an abnormal ecg t-wave.Patient was administered the following: - aspirin - plavix - heparin drip for management of acs the patient was discharged on (b)(6) 2023 with a discharge condition of: good.No impact to patient management was reported.

• Brand Name: ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT
• Common Device Name: 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: 18090784
• Report Number: 3005094123-2023-00307
• Device Sequence Number: 15120716
• Product Code: MMI
• UDI-Device Identifier: 00380740175504
• UDI-Public: 00380740175504
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 12/06/2023
• Device Catalogue Number: 02R98-35
• Device Lot Number: 53390UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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 I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 68 YR
• Patient Sex: Female