HEMOCUE HB 301 SYSTEM

Additional Manufacturer Narrative

THE CUSTOMER COULD NOT IDENTIFY EXACTLY WHICH OF THEIR ANALYZERS HAD BEEN USED AT THE TIME OF THE INCIDENT AND THEREFORE RETURNED THE 3 DEVICES THAT COULD HAVE BEEN USED. TWO OF THE ANALYZERS (B)(6) WERE INVESTIGATED AND FOUND TO BE PERFORMING ACCORDING TO SPECIFICATIONS AND NO MALFUNCTION COULD BE FOUND ON THOSE. THE THIRD ANALYZER (B)(6) PERFORMED WITHIN SYSTEM REQUIREMENT SPECIFICATION BUT MEASURED APPROXIMATELY 0.5 G/DL TOO HIGH. FURTHER INVESTIGATION CONFIRMED THAT THIS DEVIATION WAS CAUSED BY UNAUTHORIZED OPENING OF THE ANALYZER LEADING TO THE ANALYZER'S OPTIC MODULE BEING DAMAGED. THE OPTIC MODULE INCLUDES THE LIGHT DETECTOR BOARD WHICH AFFECTS A/D CONVERTER FUNCTIONING.

Description of Event or Problem

HEMOCUE AB RECEIVED A COMPLAINT ABOUT AN INCIDENT DURING A BLOOD DONATION. THE DONOR'S FIRST HEMOCUE (HB) READING WAS 10.3G/DL. SHE PERMITTED A SECOND STICK AND IT CAME BACK AS 13.3G/DL. SHE QUALIFIED FOR AND AGREED TO A DOUBLE RED COLLECTION (WHICH EFFECTIVELY REMOVES TWO RBC UNITS BY APHERESIS). SHE FELT LIGHTHEADED AFTERWARDS AND ENDED UP IN THE ER A COUPLE OF DAYS LATER WHERE HER VENOUS HEMOGLOBIN WAS CLOSE TO 7G/DL. SHE WAS HOSPITALIZED, TREATED FOR ANEMIA AND DISCHARGED. THE DONOR IS CONTINUING TREATMENT WITH HER PRIMARY CARE PHYSICIAN AND HAS DECLINED TO PROVIDE ANY SUBSEQUENT FOLLOW UP INFORMATION. THE END USER ASSUMPTION IS THAT THE SECOND HB VALUE WAS ERRONEOUSLY HIGH. THE END USER HAD THREE ACTIVE ANALYZERS (SERIAL NUMBERS: (B)(6) AT THE SITE DURING THE TIME OF THE EVENT AND IT IS NOT KNOWN WHICH OF THEM WAS USED ON THIS DONOR. THE END USER HAS INDICATED THAT THEY DO NOT BELIEVE THERE ARE ANY ISSUES WITH THE HEMOCUE DEVICES AND HAVE NOT RETURNED ANY OF THEM FOR INVESTIGATION.