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

Model Number	5700411
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when they insert batteries, their analyzer "heats up to the point of smoking".There were no allegations of patient/user harm.There were no allegations of incorrect results.
Additional Manufacturer Narrative
The customer analyzer has been returned and the investigation is currently ongoing.Submitting this initial report with a follow-up report pending the completion of the investigation.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: 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: brandon unruh ; 4600 anson blvd; whitestown, IN 46075 ; 3178705610
• MDR Report Key: 13193856
• Report Number: 1836135-2022-00005
• Device Sequence Number: 20298788
• Product Code: CGA
• UDI-Device Identifier: 00304040037713
• UDI-Public: (01)00304040037713(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): 12/09/2021

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: 5700411
• Device Catalogue Number: 5700411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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