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

Model Number 2700

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burning Sensation (2146)

Event Date 04/23/2022

Event Type  malfunction  

Event Description

The customer reported that the batteries overheated in their analyzer causing a "red mark on hand".There were no allegations of serious injury/illness.There were no allegations of incorrect results.

Manufacturer Narrative

During the investigation, it was determined that the terminal displacement is caused by the customer providing undue force onto the battery terminals causing them to drop and is not due to a manufacturing defect.Several key factors point to this decision: the battery terminals would have to have been properly seated at the time of manufacturing because the analyzer would not power on and consequently be unable to be calibrated and released.Upon close inspection of the battery terminal area, damage to the plastic component of the battery compartment was observed.Pts is confident that this damage occurred post-distribution, as there are nomanufacturing steps that would cause this type of damage.To prove the terminals could not be accidentally dislodged by proper battery insertion, the force of battery insertion and the force it takes for terminal displacement was measured.It takes roughly 3-5lbs of force to insert a battery and roughly 30lbs of force to dislodge a battery terminal.This means that the customer cannot unseat the battery terminals under the force exerted during normal battery insertion and the dislodge would likely occur when the customer attempts to forcefully remove batteries from the compartment.The customer allegation of overheating was observed on the damaged analyzer.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Type of Device: 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: 14497802
• MDR Text Key: 300443343
• Report Number: 1836135-2022-00028
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(8012)111
• 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: 05/25/2022

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
• Device Operator: Health Professional
• Device Model Number: 2700
• Device Catalogue Number: 2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/25/2022
• 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