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

Catalog Number	09P31-25
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	09/25/2023
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 27-sep-2023, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+ cartridge that yielded a discrepant potassium result of >9 mmol/l on a patient.There was no patient information at the time of this report.Method; date ; tested; result; sample; i-stat (b)(6) 2023 14:59 >9 mmol/l a.Lab (b)(6) 2023 15:30 4.30 mmol/l a.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 31-oct-2023.A review of the device history record (dhr) confirmed the cartridge lot 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 h23157.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ CARTRIDGE,
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540
• 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; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6133123525
• MDR Report Key: 17860455
• Report Number: 2245578-2023-00135
• Device Sequence Number: 6135637
• Product Code: JGS
• UDI-Device Identifier: 10054749001917
• UDI-Public: 10054749001917
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/08/2023

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: 12/03/2023
• Device Catalogue Number: 09P31-25
• Device Lot Number: H23157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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: Unknown