ULTRA

Description of Event or Problem

WE UPGRADED OUR BLOOD GLUCOSS MONITORING METER WITH THE ULTER ONLY TO FIND THAT THEY WERE GIVING GALSE READINGS CAUSING INCORRECT DOSES & INSULIN TO BE GIVEN. ONE METER WAS REPLACED BY MON. AS BEING WRONG BUT AFTER VENOUS BLOOD STUDIES WERE DONE WE FOUND THEY WERE ALL GIVING VERY LOW READINGS. WE COMPARED THE ULTRA REAQDINGS TO VENOUS (LAB) TESTS AD WELL AS WITH BG, ACCU-CK, METER AND AN AMES METER. THE ULTRA CONSISTANTLY NEED 100, 150 LOWER IN EVERY CASE. WE HAVE USED SEVEN (7) DIFFERENT ULTRA MONITORS, WHICH ALL GIVE "VERY" WRONG READINGSDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: .INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, INADEQUATE QUALITY ASSURANCE, TELEMETRY FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.