THE CUSTOMER REPORTED THAT THEY OBTAINED A FALSE ANTIBODY SCREEN RESULT WITH A PT'S SAMPLE ON THE MTS INCUBATOR. THE CUSTOMER PERFORMED INVESTIGATION AND INDICATED THAT THEIR BIOMED HAD ACCIDENTALLY KNOCKED THE POWER CORD OUT OF THE MTS INCUBATOR SHORTLY AFTER A GEL RACK HAD BEEN INSERTED. THE TECH FAILED TO NOTICE THE OUT OF RANGE INCUBATOR LIGHT (INCUBATOR POWER WAS OFF) WHEN THE INCIDENT OCCURRED. THE PT VISITED THE FACILITY 7 DAYS LATER FOR TRANSFUSION AND THE DISCREPANCY WAS NOTED UPON REPEAT TESTING FOR BLOOD WORK UP.
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Patient 1
A POSSIBLE ROOT CAUSE WAS DETERMINED. THE CUSTOMER'S BIOMED TECH INADVERTENTLY KNOCKED THE POWER CORD OUT OF THE INCUBATOR CAUSING THE INCUBATOR POWER CORD OUT OF THE INCUBATOR CAUSING THE INCUBATOR POWER TO BE OFF. SINCE THE POWER WAS OFF, THE GEL CARD IN QUESTION WAS NOT INCUBATED AT THE CORRECT TEMPERATURE, RESULTING IN THE FALSE NEGATIVE RESULTS. REPAIRS WERE NOT REQUIRED SINCE INSTRUMENT MALFUNCTION DID NOT OCCUR. USER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE CUSTOMER INDICATED IT IS NOW REQUIRED BY THEIR STAFF TO INSPECT THE POWER CORD AT THE BEGINNING OF EACH SHIFT. INCIDENT IS ISOLATED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT.