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

Catalog Number 60099001-25

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

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 06-nov-2020, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ionized calcium result of >2.5 on a patient.The test was repeated on another lot, and result was acceptable.There was no patient information available at the time of this report.Return product is available for investigation.Method: result: i-stat; >2.5; i-stat ; 1.6.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 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-dec-2020.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Af, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for cg8+ lots w20154 and w20112a.

Event Description

Na.

• 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: 10894317
• MDR Text Key: 217969535
• Report Number: 2245578-2020-00125
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Catalogue Number: 60099001-25
• Device Lot Number: W20154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1