Description of Event or Problem · 1
ACCU-CHEK INFORM METER WAS RETURNED TO CRADLE TO DOWNLOAD CONTROL RESULTS IN THE ED. DOWNLOAD HISTORY SHOWED THE STATUS AS "FAIL." NORMALLY, THE DATE AND TIME ARE SENT TO THE METER AT THE END OF A SUCCESSFUL TRANSMISSION CYCLE. IT IS UNCLEAR IF AN ERROR MESSAGE WAS DISPLAYED ON THE METER BUT IT WAS USED AGAIN TWO DAYS LATER WHEN A PATIENT TEST WAS PERFORMED. HOWEVER, THE DATE OF THE TEST WAS RECORDED AS TWO DATES BEFORE THE TEST WAS PERFORMED. THE METER WAS RETURNED TO THE CRADLE WHERE IT SUCCESSFULLY COMPLETED A TRANSMISSION CYCLE AND THE DATE WAS CORRECTED. THOUGH QUALITY CONTROL MATERIAL HAD NOT BEEN RUN FOR THE 48 HOURS, QUALITY CONTROL MATERIAL WAS RUN THE DATE OF THE DATE CORRECTION. THE ERROR WAS RECOGNIZED WHEN THE DEVICE TRIED TO RESULT INTO THE ELECTRONIC MEDICAL RECORD SOFTWARE USING THE WRONG DATE. THE METER WAS IMMEDIATELY REMOVED FROM SERVICE. BOTH ROCHE (METER MANUFACTURER) AND MEDICAL AUTOMATION SYSTEMS (CONNECTIVITY SOFTWARE COMPANY) WERE BOTH CONTACTED WITHOUT RESOLUTION TO THE PROBLEM. METER WILL BE REPLACED.==================================================================REPORTER INDICATED THEY DID NOT HAVE PRIOR SIMILAR PROBLEM WITH THIS DEVICE. THE TEST RESULTS WERE NEVER IN QUESTION. IT WAS THE TIME OF THE TEST THAT WAS RECORDED INCORRECTLY BY THE METER. CORRECT DATE AND TIME OF RESULT WERE VERIFIED AFTER SPEAKING WITH THE INSTRUMENT OPERATOR AND BY MEDICAL CHART REVIEW. OTHER DATA IN HISTORY FILE WAS NOT AFFECTED. NO OTHER BASE/METER WAS AFFECTED. BASE AND INSTRUMENT ARE STILL IN USE WITHOUT ANY RECURRENCE OF THE INCIDENT.