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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their analyzer "got very warm and hot" prior to attempting testing for the day.There were no allegations of patient/user harm.There were no allegations of incorrect results.
Additional Manufacturer Narrative
During the investigation, it was 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: 1.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.2.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.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN ; 3178705610
• MDR Report Key: 18187148
• Report Number: 1836135-2023-00043
• Device Sequence Number: 6646508
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(8012)111
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/21/2023
• 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