MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT G3+ CARTRIDGE

Catalog Number 03P78-50

Device Problem Nonstandard Device (1420)

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

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Details were provided with the action that was conducted in cooperation with the u.S.Food and drug administration.Apoc product action number: (b)(4).Fda product action number: 2245578-01/13/20-002-c.Product name: i-stat g3+ (blue) cartridge, list number: 03p78-50, udi: (b)(4).

Event Description

A remedial action has been completed to provide recommendations to the customer for product in the field.Abbott point of care is communicating this information to all potentially impacted customers in the united states (u.S.).Abbott point of care has made a decision that as of may 1, 2020, it will no longer market the cartridges listed above.Abbott point of care is providing this information so that your facility will have sufficient time to implement alternate testing plans.Facilities should transition to alternate testing methods.For facilities that have been using the g3+ (blue) cartridge, recommended actions are as follows: during the transition, clinicians and laboratory staff should be informed that the performance of the i-stat g3+ (blue) cartridge has not been fully characterized by abbott.Clinicians should be advised to consider a patient's signs, symptoms, history, and results of other diagnostic tests when interpreting results from these cartridges.If the results do not match the patient's clinical presentation, the patient sample should be retested using an alternate test method or a reference laboratory.Abbott is working closely with the u.S.Food and drug administration to bring these cartridges into compliance with all regulatory requirements and plans to submit this as a recall.Abbott point of care has not received any reports of patient harm associated with the use of blue i-stat g3+ cartridges.

• Brand Name: I-STAT G3+ CARTRIDGE
• Type of Device: G3+ 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; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540-3629 ; 6136885949
• MDR Report Key: 9601805
• MDR Text Key: 198873771
• Report Number: 2245578-2020-00016
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Catalogue Number: 03P78-50
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: APOC2020-002
• Patient Sequence Number: 1