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

Model Number 5700411

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis IN 46278
• Manufacturer (Section G): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis IN 46278
• Manufacturer Contact: brandon unruh ; 7736 zionsville road; indianapolis, IN 46278 ; 3178705610
• MDR Report Key: 8812244
• MDR Text Key: 152062105
• Report Number: 1836135-2019-00050
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00304040037713
• UDI-Public: (01)00304040037713(8012)109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1