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 Codes	Arthritis (1723); Hyperglycemia (1905); Pain (1994)
Date of Event	07/27/2019
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.Note: this incident was received as part of the abbott point of care active monitoring program q3 2019.
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 results on a (b)(6) year old male patient with pain in left arm.This incident was received as part of the abbott point of care active monitoring program q3 2019.There was no additional patient information at the time of this report.Return product is not available for investigation.(b)(6).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 11/01/2019.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing was performed using samples from three in-house donors.Testing of one sample, which has been previously shown to be challenging for the i-stat ctni assay, did not meet the acceptance criterion for either the rate of detected errors (dts) or the rate of undetected errors (udts), as outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).Testing of the other two samples passed applicable acceptance criteria.Refer to potential non-conformance quality record (qr) (b)(4) for the root cause investigation of the high rate of udts from specific in-house donor samples.A deficiency has been identified for ctni cartridge lot g19156 with respect to dts.Qr (b)(4) 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: 8939149
• Report Number: 2245578-2019-00209
• Device Sequence Number: 328976
• Product Code: MMI
• UDI-Device Identifier: 10054749001986
• UDI-Public: 10054749001986
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/13/2019

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: 01/04/2020
• Device Catalogue Number: 06P23-25
• Device Lot Number: G19156
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR