MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number 03P88-25

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

Patient Problems Hypoventilation (1916); Hypoxia (1918); Diabetic Ketoacidosis (2364); Increased Respiratory Rate (2486)

Event Date 05/12/2019

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) 2019, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant hematocrit/hemoglobin results of 42/14.3 on a (b)(6) year old female patient presented with hypoxia, increased o2 requirement on home vent.And possible seizure activity noted.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).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 customer states that the patient was transfused with prbc (1 bag) & platelets (1 bag) and appeared to be necessary based on the patient's clinical picture.There are no reports of impact to patient management.The investigation is underway.

Manufacturer Narrative

Apoc incident #:(b)(4).The investigation was completed on 07/17/2019.A review of the device history record confirmed the lot passed finished goods release criteria.Retain cartridge test results met the acceptance criteria found in q04.01.003 rev.Ad, appendix 1- product complaint level 2 and level 3 investigation procedure.Returned cartridge testing was not able to reproduce the customer's complaint.No deficiency has been identified.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Type of Device: CG8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8670742
• MDR Text Key: 147568097
• Report Number: 2245578-2019-00140
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (y/n): N
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2019
• Device Catalogue Number: 03P88-25
• Device Lot Number: W19038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR