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

Catalog Number 03P89-24

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Infarction, Cerebral (1771)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(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 on a (b)(6) male patient with a history of stroke - cerebral infarction.There was no additional patient information at the time of this report.The customer states that return product is not available for investigation.Date time collected: (b)(6) 2017 13:47, tested: 13:47, sample: finger stick, result: 4.6, method: i-stat, sample: a; (b)(6) 2017, 14:04, 14:23, venous/wb, 3.1, stago, b.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 11/28/2017.A review of the device history record confirmed that the cartridge lot passed release specifications.Retained and returned cartridge testing of pt/inr cartridge lot s17188a did not meet the acceptance criterion outlined in appendix 1 of (b)(4) (product complaint level 2 and level 3 investigation procedure) for points outside total allowable error (ea).A deficiency has been identified for pt/inr cartridge lot s17188a.Quality record (b)(4) has been initiated to address cause.

• 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: 7004146
• MDR Text Key: 92102553
• Report Number: 2245578-2017-00601
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 10054749000170
• UDI-Public: 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
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

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: 12/28/2017
• Device Catalogue Number: 03P89-24
• Device Lot Number: S17188A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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: 77 YR