H.6 investigation summary: a failure was reported on a bd bactec fx40 (p/n 442296, s/n (b)(6)).Customer reported a false positive issue on their instrument.Bd remote assistance worked with the customer obtaining and analyzing the logs.There were no abnormalities observed on the logs.The customer was sent calibration vials and remote assistance guided them through the recalibration of the station.After the calibration of the station the instrument was working properly.The root cause was unable to be determined.This is a confirmed failure of a bd product.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.This complaint is not an early life failure (elf) of the device.Since the installation of this instrument, there have been service events, including pms (preventative maintenance) which have altered the instrument from its original state.Therefore, review of the device history record (dhr) from manufacturing is not applicable.Service history review for this instrument was completed and revealed no previous complaints related to result issues.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
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