CARDIOCHEK PLUS ANALYZER
Received Jul 30, 2024 · Event occurred May 18, 2024
Report 1836135-2024-00027 · MDR key 19862269
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Pts DiagnosticsProduct problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE MALFUNCTIONED, AS THE ALLEGATION OF OVERHEATING 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.
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING TESTING THEIR CARDIOCHEK PLUS ANALYZER SHUT OFF AND OVERHEATED. THEY REPLACED THE BATTERIES AND THE ANALYZER OVERHEATED AGAIN. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.