FDA Adverse Event Malfunction Summary report: N

HEMOCUE HB 201+ SYSTEM

MDR report key: 8439783 · Received March 21, 2019

Report

Report Number: 3003044483-2019-00006
Event Type: Malfunction
Date Received: March 21, 2019
Date of Event: January 4, 2019
Report Date: March 21, 2019
Manufacturer: HEMOCUE AB
Product Code: GKR
PMA / PMN Number: K032203
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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 · 1

HEMOCUE AB RECEIVED A COMPLAINT THAT THE ANALYZER WAS SHOWING ERROR CODE E05.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
234270	HEMOCUE HB 201+ SYSTEM	HEMOGLOBIN TEST SYSTEM	GKR	HEMOCUE AB	121769

Patients

Seq	Age	Sex	Outcome	Treatment
1