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

Model Number	02R9825
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat troponin-i result for one patient sample on the architect i2000sr, serial number (b)(4).The sample was repeated and the result was in the customers normal range.The following data was provided: initial result = 21 ng/l, repeat results on isr64746 <4, <4, and <4 result from another analyzer = <4 ng/l customer¿s reference range is <4 = normal no impact to patient management was reported.
Additional Manufacturer Narrative
This issue was previously reported under mdr number 1415939-2023-00009-01 under a different suspect device.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Updated section d: suspect medical device information: d4: catalog number updated from 02r98-25 to 02r98-35.
Additional Manufacturer Narrative
Correction needed for section d4 catalog # should be 02r98-35 and not 02r98-25.
Additional Manufacturer Narrative
1415939-2023-00009-01 g3 was incorrectly entered as 1/23/2023 and should have been entered as 02/28/2023 (the date the likely cause was changed).1415939-2023-00009-02 g3 was incorrectly entered as 2/28/2023 and should have been entered as 04/03/2023 (date the correction was identified).
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed.Return testing was not performed as returns were not available.Device history record review was performed on lot 44462ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.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 assay was identified.

• Brand Name: ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I REAGENT KIT
• Common Device Name: 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: 16495511
• Report Number: 3005094123-2023-00063
• Device Sequence Number: 6611329
• Product Code: MMI
• UDI-Device Identifier: 00380740175498
• UDI-Public: 00380740175498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/28/2023

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: 03/13/2023
• Device Model Number: 02R9825
• Device Catalogue Number: 02R98-35
• Device Lot Number: 44462UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 03/08/2023; 04/13/2023; 05/03/2023; 08/24/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/15/2023; 04/14/2023; 05/08/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown