FDA 483 - Beckman Coulter, Inc. - October 16, 2017

An FDA inspection conducted between July 25 and October 16, 2017, identified significant quality system deficiencies at a medical device firm (name redacted). The inspection, documented in an FDA Form 483, revealed four primary observations. Firstly, the company lacked adequate procedures for servicing activities, specifically failing to properly review service reports, retain complete records, analyze recurring malfunctions, and clearly document service actions. This led to a flow cytometry instrument being misconfigured for nearly a year, resulting in numerous erroneous patient test results. Secondly, the firm inadequately investigated device complaints, incorrectly classifying recurring service calls for malfunctions as routine rather than reportable complaints. Thirdly, the company failed to implement its written Medical Device Reporting (MDR) procedures, neglecting to submit a timely supplemental report to the FDA about the misconfigured instrument and the widespread erroneous results. Finally, procedures for corrective and preventive actions (CAPA) were insufficient, with an incomplete investigation into the root cause of the sample probe misconfiguration. The company promised to correct the servicing and complaint issues, and corrected the MDR reporting during the inspection. The firm is required to implement robust corrective actions to address these deviations from medical device quality system requirements.