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

Catalog Number 06P23-25

Device Problem False Negative Result (1225)

Patient Problems Asthma (1726); Headache (1880); Muscle Spasm(s) (1966); Thyroid Problems (2102); Anxiety (2328)

Event Date 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 02/06/2018.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.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for ctni cartridge lot p17258.

Event Description

On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a suspected discrepant troponin result for a (b)(6) year old female patient admitted with a past medical history of anxiety; asthma, bladder spasms; fibromyalgia; hypothyroidism; ibs, migraine headache; paf, and persistent asthma presenting to the ed with post-procedural hip bleeding, found to be in atrial flutter with elevated troponin.Patient transferred to cicu with plans for emergent cath.Method: sample: collect date: collect time: results: sample: dxi , na, (b)(6) 2018, 22:04, 31.54, a.I-stat, wb, (b)(46 2018, 14:30, 0.01, b.I-stat, wb, (b)(6) 2018, 14:58, 0.01, c.Dxi, na, (b)(6) 2018, 14:30, 24.55, b.Dxi, na, (b)(6) 2018, 15:33, 22.72, d.Test times not available.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

• 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
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 7282594
• MDR Text Key: 100775433
• Report Number: 2245578-2018-00053
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 10054749000187
• UDI-Public: 10054749000187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Catalogue Number: 06P23-25
• Device Lot Number: P17258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR