MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT PT/INR CARTRIDGE

Catalog Number 03P89-24

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 07/05/2017

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) 2017, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant results of inr 1.5.There was no additional patient information at the time of this report.The customer states that return product is not available for investigation.I-stat inr = 1.5, lab result = 2.6.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

(b)(4).The investigation was completed on 10/19/2017.Retain product was tested and functioning according to specification.Return product was not available.

Manufacturer Narrative

Apoc incident # (b)(4).Justification: this is a correction for input error on date.From: 06/05/2017 to: 07/05/2017.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 11/02/2017.Retain product was tested and functioning according to specification.Return product was not available.During the process of completing the final vigilance report for this incident, which occurred in the uk, regulatory compliance discovered that pt/inr lot s17069 (the original product on this incident) was only distributed in the us and canada.Further investigation by regulatory compliance revealed that pt/inr lot s17069a was shipped to wiesbaden and subsequently distributed to the customer who reported this complaint.When this complaint was reported to apoc, the 'a' was inadvertently omitted from the cartridge lot number.A review of the device history records (dhrs) confirmed that the cartridge lots passed release specifications.Retained cartridge testing of pt/inr cartridge lot s17069 met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ab (product complaint level 2 and level 3 investigation procedure).Testing of retained cartridges from pt/inr cartridge lot s17069a could not be arranged prior to lot expiration (28-aug-17).

• Brand Name: I-STAT PT/INR CARTRIDGE
• Type of Device: PT/INR 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: 6752557
• MDR Text Key: 81370018
• Report Number: 2245578-2017-00075
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 10054749000170
• UDI-Public: (01)10054749000170
• Combination Product (y/n): N
• PMA/PMN Number: K020355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: 03P89-24
• Device Lot Number: S17069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 07/05/2017; 10/19/2017; 11/02/2017
• Supplement Dates FDA Received: 07/31/2017; 10/24/2017; 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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