MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT TROPONIN (CTNI) CARTRIDGE; CTNI CARTRIDGE

Catalog Number	06P23-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(6).Apoc labeling was evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2020, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a suspected discrepant false positive result of 0.130 ng/l on a patient.There was no additional patient information at the time of this report.Return product is not available for investigation.Method date collected tested result (unit): i-stat (b)(6) 2020 2415 2419 0.00 ng/l, i-stat (b)(6) 2020 0332 0337 130 ng/l, i-stat (b)(6) 2020 0655 0701 0.00 ng/l, i-stat (b)(6) 2020 0800 0808 0.00 ng/l.Samples: heparin tube whole blood.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.Per i-stat system manual: art: 714258-00t, reportable range: 0.00 - 50.00, reference range: 0.00 - 0.03 (represents the 0 to 97.5% range of results), reference range: 0.00 - 0.08 (represents the 0 to 99% range of results).
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on 08-jan-2021.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing could not be performed as the lot expired on 24-jun-2020, prior to the abbott aware date of 02-dec-2020.No deficiency has been identified for ctni cartridge lot g19328.

• Brand Name: I-STAT TROPONIN (CTNI) CARTRIDGE
• Common Device Name: CTNI CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 11010919
• Report Number: 2245578-2020-00133
• Device Sequence Number: 3813380
• Product Code: MMI
• UDI-Device Identifier: 10054749001986
• UDI-Public: 10054749001986
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031739
• 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): 01/12/2021

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: 06/24/2020
• Device Catalogue Number: 06P23-25
• Device Lot Number: G19328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR