MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS 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

While reviewing a returned analyzer for a different complaint allegation, anomalies consistent with heat damage were observed.Therefore this mdr is being reported although there was no allegation of overheating.There were no allegations of patient/user harm.There were no allegations of incorrect results.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

While reviewing a returned analyzer for a different complaint allegation, anomalies consistent with heat damage were observed.Therefore this mdr is being reported although there was no allegation of overheating.There were no allegations of patient/user harm.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: 8587839
• MDR Text Key: 146357040
• Report Number: 1836135-2019-00046
• Device Sequence Number: 1
• Product Code: CGA
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/18/2019
• 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