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

Model Number	2K41-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat troponin-i result for one patient.The following data was provided.Sid: (b)(6) (67 year old female), (b)(6) 2023, initial result: 0.33 ng/ml (critical), repeat results: 0.04 and 0.03 ng/ml (normal).Normal ranges: normal = /=0.3 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
This issue was previously reported under mdr number 3016438761-2023-00161 under a different suspect medical device (architect i2000sr).The suspect medical device was changed on (b)(6) 2023 to architect stat troponin-i reagent kit upon further investigation of the customer issue.Historical complaint review determined there is normal complaint activity for the lot number.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.Worldwide data from abbottlink was reviewed 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 lot number 66986un22 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16773051
• Report Number: 1415939-2023-00028
• Device Sequence Number: 3251464
• Product Code: MMI
• UDI-Device Identifier: 00380740052836
• UDI-Public: 00380740052836
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/19/2023

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: 11/30/2023
• Device Model Number: 2K41-37
• Device Catalogue Number: 02K41-37
• Device Lot Number: 66986UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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, ISR63389
• Patient Age: 67 YR
• Patient Sex: Female