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

Catalog Number	03P90-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
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 (b)(6) 2019, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a suspected discrepant false positive results on a female patient with chest pain radiating to her teeth.There was no additional patient information, date times of testing, or product lot# at the time of this report.Method: i-stat, result: 0.34 ng/ml, sample: a, day: 1.Lab, <1.0, a, 1.I-stat, 0.33 ng/ml, b, 2.Lab, <1.0, b, 2.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: 714258-00q.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 02/12/2020.The customer reported observing high i-stat ctni results that were considered discrepant from the laboratory instrument results.The customer did not disclose the associated cartridge lot(s) or a specific time frame during which the discrepant results were observed.No relevant issues were identified through a review of quality system information.No deficiency has been identified.

• 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: 9506366
• Report Number: 2245578-2019-00304
• Device Sequence Number: 2982064
• Product Code: MMI
• UDI-Device Identifier: 10054749001986
• UDI-Public: 10054749001986
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Catalogue Number: 03P90-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1