MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE; CHEM8+ CARTRIDGE,

Catalog Number	600-9008-25
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	06/29/2023
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 29-jun-2023, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+ cartridge that yielded discrepant potassium results of 9 mmol/l on a female patient.There was no additional patient information at the time of this report.Method: i-stat, date: (b)(6) 2023, k: 9 mmol/l, sample: a; i-stat , (b)(6) 2023, 9 mmol/l , a; i-stat , (b)(6) 2023 , 3.8 mmol/l , a; lab , (b)(6) 2023 , 5 mmol/l , a.Test/collection times not avail.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 03-aug-2023.A review of the device history records (dhrs) confirmed the cartridge lots met finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Al, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for chem8+ cartridge lot h23046.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ 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 ; 185 corkstown road; ottawa, ontario, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136123525
• MDR Report Key: 17297859
• Report Number: 2245578-2023-00082
• Device Sequence Number: 7061736
• Product Code: JGS
• UDI-Device Identifier: 10054749005519
• UDI-Public: 10054749005519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053110
• 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): 08/04/2023

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: 08/14/2023
• Device Catalogue Number: 600-9008-25
• Device Lot Number: H23046
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: Female