Description of Event or Problem · 1
PT WAS ADMITTED TO THE EMERGENCY DEPARTMENT OF THE HOSP WHERE A BLOOD SPECIMEN WAS COLLECTED FOR A DILANTIN ASSAY. THE SPECIMEN WAS ASSAYED ON A CO DEVICE WHICH GAVE A RESULT OF "SUPPRESSED-OIR LOW" INDICATING A VALUE WAS OBTAINED BELOW INSTRUMENT RANGE. THIS WAS REPORTED TO THE EMERGENCY DEPARTMENT AS LESS THAN 2.5 MCG/ML WITHOUT FURTHER TESTING BY LAB TECHNICIAN. THE PT WAS STARTED ON DILANTIN 500 MG IVPB. THE LAB TECHNICIAN SUBSEQUENTLY REPEATED THE ASSAY BECAUSE THE NEXT TWO SPECIMENS SHE RAN WERE ALSO LESS THAN 2/5 MCG/ML AND SHE SUSPECTED A PROBLEM WITH THE INSTRUMENT. THE REPEATED RESULT WAS "SUPPRESSED-OIR HIGH" INDICATING A VALUE ABOVE THE RANGE OF THE ASSAY. UPON DILUTION OF THE SPECIMEN WITH SALINE, A RESULT OF 51.9 MCG/ML WAS OBTAINED. THE EMERGENCY DEPATMENT WAS NOTIFIED IMMEDIATELY AND THE IV DILANTIN DISCONTINUED. THE PT WAS ADMITTED TO ICU FOR OBSERVATION, TRNSFERRED TO A REGULAR FLOOR THE NEXT DAY, AND DISCHARGED WITHOUT ANY LONG TERM ADVERSE EFFECTS. FOLLOW-UP INCLUDED EVALUATION OF THE PROCEDUR AND INSPECTION BY THE MFR OF THE INSTRUMENT. THE INSTRUMENT WAS VERIFIED TO BE OPERATIONALLY CORRECT. THE PROCEDURE HOWEVER INDICATED THAT ANY RESULTS FLAGGED AS "SUPPRESSED-OIR LOW" MUST BE DILUTED 1:1 WITH A PROTEIN BASED SAMPLE OF KNOWN VALUE TO VERIFY THAT NO DRUG IS PRESENT. IF THIS PROCEDURE HAD BEEN FOLLOWED THE HIGHLY ELEVATED DILANTIN CONCENTRATION WOULD HAVE BEEN DISCOVERED. THE LAB TECHNICIAN WAS INSERVICED ON THE PROPER PROCEDURE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO 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. RESULTS OF EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS, UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.