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

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 "the battery exploded".There were no allegations of patient/user harm.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 "the battery exploded".There were no allegations of patient/user harm.There were no allegations of incorrect results.

• Brand Name: CARDIOCHEK PA 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: 8457654
• MDR Text Key: 140154508
• Report Number: 1836135-2019-00038
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014099
• 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

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 09/17/2018
• 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