MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG7+ CARTRIDGE

Catalog Number 03P76-25

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

Patient Problem Premature Labor (2465)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.Assessment: there are no repeats on either system and different samples were tested.Reporter could not provide answer pertaining to how the blood samples were collected and transferred to the i-stat for testing.There is not enough information to determine whether an i-stat product malfunction occurred.

Event Description

On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded suspected discrepant sodium (na) result on (b)(6) male patient born premature.There were no injuries associated with this event, the patient was treated based on the lab results.There was no additional patient information available at the time of this report.Return product was not available for investigation.Method , date, collection / test time , na (mmol/l) , sample specimen type : i-stat , (b)(6) 2017, 16:40pm / 16:42pm , 112 , a , whole blood (arterial) ; siemens vista, (b)(6) 2017 , 16:40pm / 16:42pm , 142 , b , whole blood (arterial) ; at the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted (b)(6) 2017 at abbott point of care ((b)(4)).

Manufacturer Narrative

(b)(4).The investigation was completed on 10/11/2017.Retain product was tested and the customer's complaint was not reproduced.Return product was not available.

Event Description

Na.

• Brand Name: I-STAT EG7+ CARTRIDGE
• Type of Device: EG7+ 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: 6939438
• MDR Text Key: 90314633
• Report Number: 2245578-2017-00574
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000040
• UDI-Public: (01)10054749000040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940918
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Catalogue Number: 03P76-25
• Device Lot Number: N16324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2016
• 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 Outcome(s): Congenital Anomaly
• Patient Age: 3 DA