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 Consequences Or Impact To Patient (2199)

Event Date 12/14/2016

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) 2016, 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.There was no additional patient information at the time of this report.The customer states that return product is available for investigation.Date, method, sample, type, test time, result: (b)(6) 2016, i-stat, a , capillary wb , 1408 , 5.7; (b)(6) 2016, i-stat, b, capillary wb, 1413, 3.0; (b)(6) 2016, i-stat, c, capillary wb, 1433, 4.6; (b)(6) 2016, lab, d, citrated plasma , unk, 4.9.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 02/28/2017.Retain product and customer returns were tested and functioning according to specification.

• 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: 6229816
• MDR Text Key: 64070403
• Report Number: 2245578-2017-00001
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020355
• 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,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 03P89-24
• Device Lot Number: S16247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2016
• 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: 60 YR