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

Model Number	5700411
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the analyzer was "initially getting hot" when they went back to use it again it "got extremely hot".There were no allegations of patient/user harm.There were no allegations of incorrect results.Currently it is unknown whether or not the device may have malfunctioned, as the allegation could not be duplicated.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.
Event or Problem Description
The customer reported that the analyzer was "initially getting hot" when they went back to use it again it "got extremely hot".There were no allegations of patient/user harm.There were no allegations of incorrect results.

• Brand Name: CARDIOCHEK PLUS ANALZYER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis IN 46278
• MDR Report Key: 8812244
• Report Number: 1836135-2019-00050
• Device Sequence Number: 3082094
• Product Code: CGA
• UDI-Device Identifier: 00304040037713
• UDI-Public: (01)00304040037713(8012)109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: 07/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1