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

Catalog Number 09P31-25

Device Problem False Positive Result (1227)

Patient Problem Abdominal Pain (1685)

Event Date 08/17/2017

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 chem8+ cartridges that yielded suspected discrepant hematocrit results on an (b)(6) male patient who was tested for possible blood loss; blood in stool for days.There was no additional patient information.The patient was admitted on (b)(6) 2017 at 19:10 and discharged at 23:18.(b)(6).There are no injuries associated with this event.This reporting is based on limited information available.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 10/04/2017.Retain product was tested and functioning according to specification.Return product was not available.

• 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: 6875350
• MDR Text Key: 86710078
• Report Number: 2245578-2017-00301
• Device Sequence Number: 2
• Product Code: GKF
• 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: 10/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 09P31-25
• Device Lot Number: H17100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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
• Patient Age: 11 YR