MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number 03P85-50

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 07/18/2017

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 cg4+ cartridges that yielded suspected discrepant results on a patient.There was no patient information at the time of this report.The customer states that return product is not available for investigation.Date/time collected , test time, ph, method, sample, sample type: (b)(6) 2017, 19:55pm, 20:03, 7.067 i-stat, a , wb/venous and (b)(6) 2017, 20:35pm, 21:3,5 7.32 abl800, b , wb/venous.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 11/03/2017.Retain product was tested and functioning according to specification.Return product was not available.

Event Description

Na.

• Brand Name: I-STAT CG4+ CARTRIDGE
• Type of Device: CG4+ 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: 6805222
• MDR Text Key: 83750433
• Report Number: 2245578-2017-00277
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 10054749002266
• UDI-Public: (01)10054749002266
• Combination Product (y/n): N
• PMA/PMN Number: K982071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Catalogue Number: 03P85-50
• Device Lot Number: D17086C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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