MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINICAL CHEMISTY 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	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual inspection of the battery compartment, plastic case damage indicative of improper/forceful removal of the batteries with a foreign object was observed.Pts is confident that this damage occurred post-distribution, as there are no manufacturing steps that would cause this type of damage.The customer allegation of overheating was not observed on the returned analyzer.Numerous battery compartment improvements have already been implemented prior to these allegations from the field.Process improvements and part specifications have enhanced seating and hold capacity of the battery contacts.Additionally, a new battery compartment design (approved by the fda per k193406) eliminates the potential for overheating by removing the point of contact that an unseated terminal would reach.
Event or Problem Description
Contact stated that when batteries are inserted into their cardiochek plus it gets hot to the touch.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• Manufacturer Contact: randall cundiff ; 4600 anson blvd; whitestown, IN 46075
• MDR Report Key: 22215198
• Report Number: 1836135-2025-00010
• Device Sequence Number: 20866002
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(8012)1.11
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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