AUTOLOG IQ

Additional Manufacturer Narrative

DEVICE EVALUATION: THE REPORTED ISSUE THAT THE BLOOD FROM THE RESERVOIR WAS SENT INTO THE WASTE BAG MEANING THERE WAS NOT ENOUGH VOLUME FOR RETURN WAS VERIFIED DURING SERVICE. THE ISSUE WAS RESOLVED BY CLEANING THE OPTICAL SENSORS.PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE BLOOD FROM THE RESERVOIR WAS SENT INTO THE WASTE BAG MEANING THERE WAS NOT ENOUGH VOLUME FOR RETURN. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.