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

Catalog Number	03P88-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant hematocrit results of 28.0 & 23.0 on a patient.There was limited information and no patient information.Product lot information was not presented, but requested.Method, date, tested, hb , hct.I-stat, (b)(6) 2021, 01:10, 9.5 g/dl, 28.0 %pcv.Lab, (b)(6) 2021, 03:00, 4.2 g/dl, 16.3 %pcv.I-stat, (b)(6) 2021, 03:06, 7.8 g/dl, 23.0 %pcv.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.Product lot information was not presented, but requested.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4) the investigation was completed on 18-aug-2022.Multiple attempts to obtain the cg8+ lot number from the customer were unsuccessful.Two cg8+ lots that were shipped to the customer before the test date of (b)(6) 2021, w21298 and w21316, were investigated.A review of the device history records confirmed the lots passed finished goods release criteria.Retained cartridge testing was not possible as the two potential cg8+ lots were expired (24-jun-2022 for lot w21298 and 12-jul-2022 for lot w21316) before the opening of the investigation.No deficiency has been identified.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Common Device Name: 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: 15073215
• Report Number: 2245578-2022-00097
• Device Sequence Number: 12141345
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K940918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03P88-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown