MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG7+ CARTRIDGE

Catalog Number	03P76-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoxia (1918); Respiratory Failure (2484)
Date of Event	10/30/2022
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) 2022, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded a suspected descrepant hemglobin results on a 50 year old male patient with acute respiratory failure & hypoxia.There was no additional patient information available at the time of this report.Return product is not available for investigation.I-stat 30-oct-2022 22:00 22:03 29 mmhg 94 mmhg, lab 30-oct-2022 22:27 22:37 48.4 mmhg 184.50 mmhg.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 13-dec-2022.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for eg7+ cartridge lot n22165.

• Brand Name: I-STAT EG7+ CARTRIDGE
• Common Device Name: EG7+ 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: 15796374
• Report Number: 2245578-2022-00159
• Device Sequence Number: 17341011
• Product Code: CHL
• UDI-Device Identifier: 10054749000040
• UDI-Public: 10054749000040
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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 Expiration Date: 02/11/2023
• Device Catalogue Number: 03P76-25
• Device Lot Number: N22165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2022
• 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 Age: 50 YR
• Patient Sex: Male