HEMOCUE HB 201+ SYSTEM
Received Mar 21, 2019 · Event occurred Jan 14, 2019
Report 3003044483-2019-00007 · MDR key 8439781
Device
Product problems
- Computer Software Problem
- Solder Joint Fracture
- Computer Software Problem
- Solder Joint Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE ANALYZER WAS SENT TO HEMOCUE AB WHERE THE CUSTOMER PROBLEM WAS CONFIRMED, IT WAS DISCOVERED THAT THE EEPROM MEMORY HAD BEEN CORRUPTED. THE ROOT CAUSE WAS FOUND TO BE A GLITCH IN THE CONNECTION BETWEEN COMPONENTS ON THE MAIN BOARD WHICH HAS CAUSED READ AND WRITE ERRORS LEADING TO CORRUPT VALUES IN EEPROM MEMORY. THE ERROR IN EEPROM MEMORY WILL BE PERMANENT IF THE ROOT CAUSE IS HAPPENING IN COMBINATION WITH OTHER IDENTIFIED SCENARIOS LEADING TO POTENTIAL INCORRECT MEASUREMENTS VALUES. CORRECTIVE ACTION IS TO IMPROVE THE SOLDERING PROCESS OF COMPONENTS ON THE MAIN BOARD. NOTE, WHEN THE ROOT CAUSE IS NOT OCCURRING IN A COMBINATION WITH THE IDENTIFIED SCENARIOS IT WILL LEAD TO AN ERROR CODE AND NO RESULTS WILL BE DISPLAYED.
Description of Event or Problem
HEMOCUE AB RECEIVED A COMPLAINT THAT THE ANALYZER WILL NOT POWER ON AND WAS SHOWING ERROR CODES.