MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	1.11
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There were no allegations of patient/user harm or incorrect results.Report being filed out of an abundance of caution.The customer reported that their cardiochek plus analyzer "smells like burning/smoking as though there is an electrical failure".The customer did not report that their analyzer got hot/warm to touch.
Additional Manufacturer Narrative
Currently it is unknown whether the device may have malfunctioned, as the device has not been evaluated (follow-up report will be sent promptly following investigation).It is known that improper insertion of batteries - in any device - may result in overheating, battery leakage, etc., which is stated in the labeling of most battery manufacturers.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown
• Manufacturer Contact: randall cundiff ; 4600 anson blvd; whitestown, IN 46075
• MDR Report Key: 24077237
• Report Number: 1836135-2026-00001
• Device Sequence Number: 21169798
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(8012)
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K140068
• 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
• Report Date (Section B): 01/14/2025

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 Model Number: 1.11
• Device Catalogue Number: 2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown