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

Catalog Number 03P85-25

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

Patient Problems No Information (3190); No Code Available (3191)

Event Date 11/27/2018

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 12/07/2018, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges (lot# unk) that yielded suspected discrepant results on an (b)(6) patient with diabetes.The customer stated that the patient was already very critical when admitted and later expired.Cause of death is unknown at the time of this report.There was no additional patient information available at the time of this report.Method, date, result, sample: i-stat, (b)(6) 2018, <0.30 mmol/l, a.Architect, (b)(6) 2018, 11.2 mmol/l, b.Lab, (b)(6) 2018, 10.8 mmol/l, b.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 02/19/2019.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for cg4+ lot m18163a.

• 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: 8180347
• MDR Text Key: 130883877
• Report Number: 2245578-2018-00317
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 01005474900132
• UDI-Public: 1005474900132
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K982071
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P85-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 13 YR