DAAVLIN

Description of Event or Problem

BIOMED, (B)(6), CALLED TO VERIFY THEY HAD FOLLOWED PROPER PROCEDURE IN CALIBRATING THEIR MEDICAL DEVICE. CORRECT PROCEDURE WAS NOT FOLLOWED; THEY DID NOT USE A DAAVLIN APPROVED LIGHT METER AND OUTPUTS RECEIVED WERE NOT ACCURATE, THEY ALSO DID NOT FOLLOW THE DOSE CORRECTION PROCEDURE PROPERLY. WE INFORMED THEM THAT TREATING PTS WITH THE VALUE THEY ENTERED COULD RESULT IN OVER TREATMENT. WE WERE INFORMED THAT AT LEAST ONE PT HAD ALREADY BEEN TREATED, RESULTING IN SERIOUS ERYTHEMA REQUIRING MEDICAL TREATMENT, AS CALIBRATION OF THE DEVICE HAD BEEN 2 WEEKS PRIOR. DAAVLIN COOPERATED WITH (B)(6) FOR RECALIBRATION AND SAFETY CHECKS ON (B)(4) 2012, WITH ONSIGHT VISIT. FOLLOW UP CONVERSATION WITH (B)(6) INDICATES (B)(6) WAS CONDUCTING A LINKED INVESTIGATION, BUT REFUSED TO RELEASE PT INFO TO DAAVLIN DUE TO PT PRIVACY POLICY GROUNDS.

Additional Manufacturer Narrative

DAAVLIN DEVICE WAS CALIBRATED WITH NON-DAAVLIN APPROVED METER. IT IS BELIEVED THAT THE NATIONAL BIOLOGICAL METER IS INTENDED TO CALIBRATE THEIR DEVICES WITH THE METER CLOSER TO THE LAMPS (ON THE GRID) WHILE DAAVLIN'S METERS ARE INTENDED TO CALIBRATE DEVICES BY MEASURING UV FLUX AT THE POINT WHERE THE PT'S SKIN WILL BE. THE LOW OUTPUT RECORDED IN THIS CASE BY THE NATIONAL BIOLOGICAL METER SHOWS THAT THIS COULD BE A SERIOUS SAFETY CONCERN IF NATIONAL BIOLOGICAL METERS ARE NOT METEROLOGICALLY ACCURATE AT COMMONLY USED CALIBRATION DISTANCES.