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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 19-oct-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 0.24 ng/ml on a patient.There was no patient information at the time of this report.Method: date: result: i-stat; (b)(6) 2020; 0.24.I-stat; (b)(6) 2020; 0.00.Sample collection/test times not reported.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 16-nov-2020.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for ctni cartridge lot u20134.

• 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: 10748067
• Report Number: 2245578-2020-00111
• Device Sequence Number: 14316851
• 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): 11/18/2020

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: 12/12/2020
• Device Catalogue Number: 06P23-25
• Device Lot Number: U20134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1