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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER
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PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER Back to Search Results
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 they, by accident, put one battery in the wrong way and the analyzer got "hot fast".There were no allegations of patient/user harm.There were no allegations of incorrect results.This report is being provided based on the product correction response form submitted by the customer on 3/2/2020 as part of res (b)(4).Customer was contacted for further detail, there was no allegation of injuries.Currently it is unknown whether or not the device may have malfunctioned, as the device was not returned.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 they, by accident, put one battery in the wrong way and the analyzer got "hot fast".There were no allegations of patient/user harm.There were no allegations of incorrect results.
 
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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 Key9905389
MDR Text Key208408211
Report Number1836135-2020-00028
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140068
Number of Events Reported1
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
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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