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	No Information (3190)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 08/15/2019, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a suspected discrepant troponin results on a (b)(6) male 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: positive cut-off: value: i-stat, (b)(6) 2019, 09:51, 09:51, 0.01 ng/ml, 0.08; dimension exl, (b)(6) 2019, 09:40, 09:45, 0.196 ng/ml, 0.056.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 09/10/2019.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.Ad (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for ctni cartridge lot k19043a.

• 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: 8939153
• Report Number: 2245578-2019-00212
• Device Sequence Number: 16774416
• Product Code: MMI
• UDI-Device Identifier: 10054749001986
• UDI-Public: 10054749001986
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 09/11/2019

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: 09/13/2019
• Device Catalogue Number: 06P23-25
• Device Lot Number: K19043A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR