SC100 PE PROFESSIONAL EDITION SCALE

Additional Manufacturer Narrative

H3 DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE USER FELL WHEN STEPPING OFF THE SCALE. A DEVICE QUALITY ISSUE COULD NOT BE CONFIRMED THAT WOULD CONTRIBUTE TO THE FALL. THIS ISSUE CAN OCCUR WITH FOOT MIS-PLACEMENT ON THE SCALE. THE SCALE USER MANUAL INCLUDES A CAUTION STATEMENT RELATED TO FOOT PLACEMENT ON THE SCALE, INDICATING THAT A FAILURE TO STEP ON THE SCALE CORRECTLY MAY CAUSE A LOSS OF BALANCE AND THAT FEET SHOULD BE PLACED IN THE CENTER TO ENSURE THAT THE WEIGHT IS EVENLY DISTRIBUTED AWAY FROM THE EDGES. INDIVIDUALS THAT ARE UNSTABLE SHOULD NOT USE THE SCALE AS THIS MAY RESULT IN A FALL OR INJURY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

THE SCALE WAS NOT RETURNED TO MEDTRONIC AFTER MULTIPLE ATTEMPTS TO CONTACT THE COMPLAINANT TO OBTAIN ADDITIONAL EVENT DETAILS AND TO REQUEST RETURN OF THE DEVICE. INVESTIGATION BY MEDTRONIC DETERMINED THE SC100 SCALE COVER IS DESIGNED WITH A TEXTURED SURFACE TO PROVIDE FRICTION AGAINST SLIPPING, AND THE COVER IS REMOVABLE BY DESIGN TO ENSURE ACCURACY OF THE WEIGHT READINGS. MEDTRONIC WAS ABLE TO REPLICATE THE REPORTED COVER SEPARATION ON A DIFFERENT SC100 SCALE BY APPLYING PRESSURE TO THE CORNER WHEN STEPPING OFF THE SCALE. THE SCALE USER MANUAL INCLUDES A CAUTION STATEMENT RELATED TO FOOT PLACEMENT ON THE SCALE, INDICATING THAT A FAILURE TO STEP ON THE SCALE CORRECTLY MAY CAUSE A LOSS OF BALANCE AND THAT FEET SHOULD BE PLACED IN THE CENTER TO ENSURE THAT THE WEIGHT IS EVENLY DISTRIBUTED AWAY FROM THE EDGES. IF WEIGHT IS APPLIED TO THE CORNER OF THE SCALE, THERE IS A POTENTIAL FOR THE COVER TO LIFT DUE TO THE UNEVEN PRESSURE APPLIED TO THE EDGE. WHEN USED WITH CORRECT FOOT PLACEMENT, THE SCALE COVER WILL SECURELY REST ON TOP OF THE SCALE. INDIVIDUALS THAT ARE UNSTABLE SHOULD NOT USE THE SCALE AS THIS MAY RESULT IN A FALL OR INJURY. THERE ARE NO PRIOR REPORTED COMPLAINTS FOR A PATIENT FALL DUE TO THE COVER COMING OFF THE SCALE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

THE USER REPORTED FALLING WHILE IN THE PROCESS OF STEPPING OFF THE SCALE, SUSTAINING A LEFT HIP FRACTURE DUE TO THE FALL. THE USER REPORTED THAT THEY LOST THEIR BALANCE WHEN STEPPING OFF THE SCALE AND THAT THE COVER CAME OFF OF THE SCALE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION OR PRODUCT ANALYSIS.