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

Catalog Number 600-9001-25

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

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

Event Date 12/11/2021

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) 2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ionized calcium result of 1.56 mg/dl on a patient.There was no additional patient information.Method: i-stat , date: (b)(6) 2021 , k results: 1.56 mg/dl ; method: lab , date: (b)(6) 2021 , k results: 0.72 mg/dl.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 22-dec-2021.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing for the lot met the acceptance criteria found in q04.01.003 rev.Ag, appendix 1- product complaint level 2 and level 3 investigation procedure for suppressed results and for points outside total allowable error (ea) for all sensors except ica.This related deficiency is being investigated in quality record (b)(4).

Event Description

Na.

Manufacturer Narrative

Apoc incident: # (b)(4).A memo regarding the investigation was completed on 13-may-2022.The memo determined that lot w21139a which was previously identified as a deficiency for ica points outside total allowable error was inadvertently bracketed with qr 775835.As a result qr 823211 was initiated to bracket lot w21139a.This follow up does not change the outcome of the investigation and solely for bracketing purpose.

• 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
• 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 ; 6136885949
• MDR Report Key: 13059604
• MDR Text Key: 290066811
• Report Number: 2245578-2021-00109
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Catalogue Number: 600-9001-25
• Device Lot Number: W21139A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 05/13/2022
• Supplement Dates FDA Received: 01/05/2022; 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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