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 after batteries were inserted the analyzer "ran hot".The customer also reported that after the incident the analyzer had been giving erratic cholesterol results.There were no allegations of patient/user harm.The returned analyzer was investigated for both the recovery and allegation of overheating.The returned analyzer and qc retains testing measured within specification for cholesterol.At no point during testing did the returned analyzer overheat.Currently it is unknown whether or not the device may have malfunctioned, as the allegations 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 after batteries were inserted the analyzer "ran hot".The customer also reported that after the incident the analyzer had been giving erratic cholesterol results.There were no allegations of patient/user harm.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown, in
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown, in
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, in ; 8705610
• MDR Report Key: 9905382
• MDR Text Key: 200580146
• Report Number: 1836135-2020-00029
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(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: 03/31/2020

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: 03/18/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1