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

Model Number	2702
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer provided a log sheet of 6 analyzers with the same complaint description.All 6 analyzers have the same allegation, "the analyzer got very hot and now there is corrosion".There were no allegations of patient/user harm for any of the reported incidents.There were no allegations of incorrect results.Each analyzer will receive its own medwatch form.
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have malfunctioned, as the allegation of overheating could not be duplicated.Corrosion was observed in the battery compartment of the returned analyzer.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: CARDIOCHECK 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: 16704322
• Report Number: 1836135-2023-00007
• Device Sequence Number: 20251435
• Product Code: CGA
• UDI-Device Identifier: 00381932702010
• UDI-Public: (01)00381932702010(8012)1.11
• 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): 04/07/2023

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
• Device Model Number: 2702
• Device Catalogue Number: 2702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/07/2023
• 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