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Issue:

The FDA recalled a blood pressure device that our customer used in ongoing field trial. Ancillare needed to identify product specifications, number of units required, logistical restrictions, field training requirements and delivery deadlines. The device required must be a diagnostic tool, equipped to take a minimum of three patient readings, mercury free, battery operated with electrical adapter for specific country of use, FDA approved, and mobile. A total of 175 units were required for immediate shipment worldwide.

Additional Logistical Constraints/Restrictions

	Unit must be cleared to ship throughout South America, EU, and India
	APT to supply all necessary documentation – shipping proformas, C of O's, RoHs, harm codes, etc. at time of quotation.
	Ancillare inventory, supply, return, recalibration of equipment and deployment programs were established.
	Field training programs wer developed and conducted.

End Result

	APT Medical Director identified the BpTRU Blood Pressure Device and the clinical teams.
	Ancillare programs were immediately rolled out and launched within 5 days of award.
	Units were released to sites with minimal down time.

Note

The BpTRU product has been standardized in all trials requiring a diagnostic blood pressure reading and the program continues today.