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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported that an associate inserted the batteries and the analyzer overheated.They also stated that they removed the batteries and put them back in and the analyzer was fine.There was no allegation of patient/user harm.There was no allegation of incorrect results.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 that an associate inserted the batteries, and the analyzer overheated.They also stated that they removed the batteries, and put them back in and the analyzer was fine.There was no allegation of patient/user harm.There was no allegation 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 
MDR Report Key10905698
MDR Text Key219538371
Report Number1836135-2020-00046
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 11/25/2020
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
Initial Date Manufacturer Received 10/28/2020
Initial Date FDA Received11/25/2020
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 Number1
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