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

Model Number 2700

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The customer reported that when inserting new batteries they "immediately got hot, melted the batteries, and burnt her fingers".The customer stated that the burn was minor requiring no treatment.There were no allegations of death or serious injury.There were no allegations of incorrect results.The analyzer was returned.The returned analyzer was investigated by product support and engineering and the customer complaint could not be duplicated.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 when inserting new batteries they "immediately got hot, melted the batteries, and burnt her fingers".There were no allegations of death or serious injury.There were no allegations of incorrect results.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• 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: 8457658
• MDR Text Key: 140154213
• Report Number: 1836135-2019-00035
• 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: 03/27/2019

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
• 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: 01/08/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 03/27/2019
• 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