HEMOCUE HB 201 DM SYSTEM
Received Jan 10, 2019 · Event occurred Dec 12, 2018
Report 3003044483-2019-00005 · MDR key 8235579
Device
Generic name
Hemoglobin Test System
Manufacturer
Hemocue AbProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
HEMOCUE (B)(4) RECEIVED A COMPLAINT STATING THAT THE CUSTOMER WRONGLY USED A BLOOD SUGAR POCT MACHINE, GLUCOSE 201 DM ANALYZER, TO CHECK THE HB VALUE DURING SURGERY DUE TO A MIX-UP OF THE TWO TYPES OF ANALYZERS (GLUCOSE 201 DM AND HB 201 DM). CONSEQUENTLY THE ANAESTHETIST REQUESTED (AND PATIENT WAS ADMINISTERED) 2 UNITS OF O NEGATIVE BLOOD AS THE RESULT ON THE MACHINE SAID 5.9. THE PATIENT WAS UNNECESSARILY ADMINISTERED 2 UNITS OF O NEGATIVE BLOOD DURING SURGERY AND LATER 2 UNITS OF FFP WAS GIVEN ON CLINICAL GROUNDS.
Additional Manufacturer Narrative
INVESTIGATION AT HEMOCUE AB CONCLUDED THAT THE ANALYZERS AND MICROCUVETTES WERE DESIGNED ACCORDING TO SPECIFICATIONS, THE PRODUCT NAME IS CLEARLY VISIBLE ON THE ANALYZERS AND THE MICROCUVETTE PACKAGES AND POUCHES ARE DIFFERENTIATED BY DIFFERENT "COLOR CODES", RED FOR HB AND BLUE FOR GLUCOSE. THE CUSTOMER CONFIRMED THAT THE ANALYZERS WORKED AS INTENDED AS THEY WERE VERY RECENTLY SERVICED AND AS WELL CONFIRMED IT HAS BEEN A HUMAN ERROR BY THE OPERATOR (AGENCY STAFF) IN HANDLING THE DEVICES USED DURING SURGERY. ADDITIONAL TRAINING HAS BEEN CONDUCTED AT CUSTOMER SITE.