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

Catalog Number	06P23-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	10/28/2019
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 troponin result of 0.00 on a (b)(6) year old female patient with chest pain.There was no additional patient information at the time of this report.Return product is available for investigation.Method: i-stat, date: 10/28/2019, collected: 09:37, tested: 09:44, result: 2.51 ug/l, sample: a.I-stat, 10/28/2019, 15:40, 15:55, 0.00 ug/l, b.I-stat, 10/28/2019, 15:40, 16:07, 3.24 ug/l, b.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.There is evidence the patient suffered an mi.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 12/16/2019.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Returned cartridge testing met the acceptance outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).A deficiency for ctni cartridge lot g19198 has been identified.Retained cartridge test event ec155 met the acceptance criterion for the undetected error (udt) rate, but not for the detected error (dt) rate, as outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).Quality record (qr) 708510 will document the root cause investigation.

• 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: 9283904
• Report Number: 2245578-2019-00260
• Device Sequence Number: 2003204
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 02/15/2020
• Device Catalogue Number: 06P23-25
• Device Lot Number: G19198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR