Cepheid Lands Form 483 for Design Validation, CAPA Failures
The FDA inspector noted that design validation for the Xpert MRSA diagnostic test did not ensure that the device conforms to defined user needs and intended uses.
Specifically, the qualitative in vitro diagnostic that tests for methicillin-resistant Staphylococcus aureus infection produced false negative results in neonatal infants, and the device has not been validated for that patient population, the Form 483 says.
The inspector notes that the firm consulted with hospital clinical laboratories in July 2012 regarding neonatal tests results, which resulted in an FDA MedWatch filed on Sept. 20, 2012. An earlier MedWatch that resulted in a patient death had been filed in 2010.
The 483 notes that the firm’s risk analysis did not take into account potential risks and differences associated with the product in children and infants.
The FDA also cited the firm for failing to file MDR reports within the required 30-day filing window. A further review of the firm’s complaint handling procedures revealed that complaints about the device were not reviewed and evaluated, and the firm did not conduct an investigation.
A complete review revealed “no written records of external communications and/or investigations and/or evaluations with medical user-facility regarding false negative results with the device,” even though the firm had consulted with the hospital about the failures, the 483 notes.
The FDA earlier hit Cepheid with a July 23 warning letter for not taking corrective actions at its Solna, Sweden, facility, which serves as the company’s European manufacturing and research and development site.
The firm did not respond to a request for comment.
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