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

Model Number	1.12
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the investigation, it is determined that the terminal displacement is most likely caused by the customer providing undue force onto the battery terminals.In addition, the potential exists for the battery contact to lose traction with the compartment causing less force to dislodge however improper removal of batteries will still force the dislodge.Several key factors point to this decision: the battery terminals would have to have been properly seated at the time of manufacturing because the analyzer would not power on and would consequently be unable to be calibrated and released.Upon close inspection of the battery terminal area, it was observed that the terminals were fully seated initially due to visible drag marks created by the metal terminal scraping the plastic casing when excessive force was applied.These markings are present from the point of terminal seating down to where the terminals lie currently.Pts is confident that this damage occurred post-distribution, as there are no manufacturing steps that would cause this type of damage.
Event or Problem Description
There were no allegations of patient or user harm.The customer reported that upon battery installation, their analyzer's battery compartment "got really hot and brand-new batteries exploded after removing them from the analyzer.No one was injured.".

• 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 IN 46075
• Manufacturer Contact: randall cundiff ; 4600 anson blvd; whitestown, IN 46075
• MDR Report Key: 22812871
• Report Number: 1836135-2025-00012
• Device Sequence Number: 18332021
• Product Code: CGA
• UDI-Device Identifier: 00381932701013
• UDI-Public: (01)00381932701013(8012)1.12
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/14/2025

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: 1.12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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