MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINCIAL 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	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual inspection of the battery compartment, corrosion consistent with the reported improper storage of the returned analyzer 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 "batteries exploded inside the analyzer" was not observed during testing of the returned analyzer.Proper storage and handling of cardiochek analyzers as outlined in the included user guide was not followed by the customer, leading to the reported malfunction, which was not duplicated during testing of the returned analyzer by the manufacturer(pts diagnostics).
Event or Problem Description
There were no allegations of patient or user harm.This report is being filed out of an abundance of caution.The customer used the verbiage "the battery exploded inside the analyzer" to describe an event in which "the pharmacy was attempting to run routine qc on analyzer today which wouldn't turn on so they opened the compartment door and noticed that a battery had split open in the analyzer." this analyzer was being used beyond it's recommended device life and the customer reported that they were not following proper storage procedures found in the user guide (ps-004561-en rev 6), which states that batteries should be removed when cardiochek analyzers are not in use.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Common Device Name: CLINCIAL 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: 22163831
• Report Number: 1836135-2025-00008
• Device Sequence Number: 8841947
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2025

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: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/07/2025
• 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