AUTOLOG IQ

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG INSTRUMENT IQ, IT WAS REPORTED THAT BLOOD PASSED INTO THE WASTE BAG. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE OF BLOOD PASSING INTO THE WASTE BAG WAS NOT VERIFIED DURING SERVICE AS NO ISSUES WERE OBSERVED DURING THE SERVICE. THE SERVICE TECHNICIAN CLEANED THE INSTRUMENT AND ADJUSTED VR1 AND VR2. SERVICE TECHNICIAN ALSO COMPLETED PERFORMANCE VERIFICATION, FUNCTIONAL CHECK AND ELECTRICAL SAFETY TESTING. POST-REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. D9: INSTRUMENT WAS SERVICED AT THE FACILITY BY MEDTRONIC FIELD SERVICE AND WAS NOT RETURNED TO MEDTRONIC SERVICE CENTER 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.