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

Catalog Number	09P31-26
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	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-mar-2023, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+ cartridge that yielded discrepant potassium & hematocrit results on a patient.There was no additional patient information at the time of this report.Return product is available for investigation.Method: i-stat, date: (b)(6) 2023, collected: 06:59, tested: 07:04, hct: 22, k: 2.8, sample: wb; dxh900, (b)(6) 2023, 06:59, 07:24, 43.2, ni, wb; beckman, (b)(6) 2023, 06:59, 07:24, ni, 4.1, wb.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).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 19-apr-2023.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained and returned cartridge 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 chem8+ cartridge lot h23017.
Event or Problem Description
Na.

• 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; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136885949
• MDR Report Key: 16677789
• Report Number: 2245578-2023-00028
• Device Sequence Number: 5298113
• 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): 04/26/2023

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: 07/16/2023
• Device Catalogue Number: 09P31-26
• Device Lot Number: H23017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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 Age: 79 YR
• Patient Sex: Female