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

Catalog Number	02K41-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 patient identifier complete information: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results generated on the architect i2000sr processing module for one sample.(customer¿s normal reference range - <= 0.04 ng/ml, critical value - >= 0.10 ng/ml).Sid (b)(6) original result was 0.11 ng/ml (critical) (isr63388).Repeated on 2nd analyzer twice (isr63385): 0.05 ng/ml, 0.06 ng/ml.Repeated on original analyzer five more times (isr63388): 0.04 ng/ml, 0.04 ng/ml, 0.04 ng/ml, 0.05 ng/ml, 0.05 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect stat troponin-i results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Review of all the information provided by the customer was reviewed.A ticket search for lot 98913un23 identified an increase in complaint activity related to the falsely elevated patient results; however, no trends were identified.Device history review did not identify any potential non-conformances, deviations, or non-conformances with the complaint lot.The overall performance of architect stat troponin-i reagent was reviewed using data gathered from customers worldwide.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.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 troponin-i reagent lot 98913un23 was identified.All available patient information was included.Additional patient details are not available.Corrected information in section d4- expiration date.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results generated on the architect i2000sr processing module for one sample.(customer¿s normal reference range - <= 0.04 ng/ml, critical value - >= 0.10 ng/ml) sid (b)(6)original result was 0.11 ng/ml (critical) ((b)(6)) repeated on 2nd analyzer twice ((b)(6)): 0.05 ng/ml, 0.06 ng/ml repeated on original analyzer five more times ((b)(6)): 0.04 ng/ml, 0.04 ng/ml, 0.04 ng/ml, 0.05 ng/ml, 0.05 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: 17949896
• Report Number: 1415939-2023-00056
• Device Sequence Number: 7669694
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: 00380740052836
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 02/29/2024
• Device Catalogue Number: 02K41-37
• Device Lot Number: 98913UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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, ISR63388, ISR63385
• Patient Sex: Unknown