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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the analyzer was "very hot to the point that the batteries were slightly melted." 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 (b)(6) 2020 as part of res (b)(4).The customer was contacted for further detail and there were no allegation of injuries.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 the analyzer was "very hot to the point that the batteries were slightly melted." 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 Key9823257
MDR Text Key200629819
Report Number1836135-2020-00023
Device Sequence Number1
Product Code CGA
UDI-Device Identifier0381932700016
UDI-Public(01)0381932700016(8012)111
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 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2020
Date Manufacturer Received02/12/2020
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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