MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number 09P31-25

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On 07/06/2016, abbott point of care was contacted by a customer regarding i-stat chem8+ cartridges that yielded suspected discrepant na, & ci results on a patient.There was no patient information at the time of this report and the customer states they are unable to provide any additional information for patient.The customer also states that return product is available for investigation.Patient lot# test date time na cl patient: #9, lot# h16124, test date: (b)(6) 2016, time: 2025, na: 115, cl: >140; repeat, h16124, (b)(6) 2016, 2033, 140, 103.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

(b)(4).The investigation was completed on 08/29/2016.Retain product was tested and is functioning according to specification.Return product was not available for investigation.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Type of Device: CHEM8+ 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: 5789917
• MDR Text Key: 50216324
• Report Number: 2245578-2016-00053
• Device Sequence Number: 1
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053110
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Catalogue Number: 09P31-25
• Device Lot Number: H16124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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