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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
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 15-mar-2022, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded a suspected discrepant potassium result of 5.0 mmol/l on a 72 year old female patient in a coma, and end-stage chronic renal failure.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method, date, collected, tested, results, sample; i-stat, (b)(6) 2022, 10:10, 10:14, 5.0 mmol/l, a; lab, (b)(6) 2022, 09:28, 10:28, 6.8 mmol/l, b.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 06-apr-2022.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.Ag, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for eg7+ cartridge lot n22028.

• 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: 13869189
• Report Number: 2245578-2022-00058
• Device Sequence Number: 5295616
• Product Code: CHL
• UDI-Device Identifier: 10054749000040
• UDI-Public: 10054749000040
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 04/14/2022

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: 09/27/2022
• Device Catalogue Number: 03P76-25
• Device Lot Number: N22028
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: 72 YR
• Patient Sex: Female