CARDIOCHEK PLUS ANALYZER
Received Oct 24, 2024 · Event occurred Sep 21, 2024
Report 1836135-2024-00038 · MDR key 20525726
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 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.
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHEN INSERTING NEW BATTERIES INTO THEIR ANALYZER, THE BATTERIES "GOT HOT, OVERHEATED, AND SPLIT (LIKELY REFERRING TO THE PLASTIC BATTERY LABEL)." THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.