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

Catalog Number 06P90-25

Device Problem False Positive Result (1227)

Patient Problems Hyperventilation (1910); Nausea (1970); Respiratory Distress (2045); Anxiety (2328); Diaphoresis (2452)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Apoc incident (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event 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 on a (b)(6) year old female patient with shortness of breath, hyperventilation, diaphoretic, nausea.There was no additional patient information at the time of this report.Return product is 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 patient was discharged to follow up with cardiologist.Based on the patient's clinical picture there is no 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).

Event Description

Na.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 09/24/2019.A review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained and 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).No deficiency has been identified for ctni cartridge lot d19170.

• Brand Name: I-STAT TROPONIN (CTNI) CARTRIDGE
• Type of Device: CTNI CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 9077664
• MDR Text Key: 195933763
• Report Number: 2245578-2019-00222
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 10054749000187
• UDI-Public: 10054749000187
• Combination Product (y/n): N
• PMA/PMN Number: K031739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Catalogue Number: 06P90-25
• Device Lot Number: D19170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR