Description of Event or Problem · 0
CURRENT HEALTH IS A UK BASED COMPANY THAT WAS ACQUIRED BY BEST BUY. SINCE THE ACQUISITION, BEST BUY CORPORATION HAS BEEN MAKING DECISIONS ON THE MEDICAL DEVICE (CURRENT HEALTH PLATFORM). SINCE THE LAST TRADITIONAL 510(K) IN 2021 (K210133), THE COMPANY HAS MADE MANY CHANGES TO THE DEVICE IN RESPONSE TO CRITICAL INCIDENTS THAT WERE REPORTED BY CUSTOMERS. IN THE PAST 3 MONTHS ALONE, THESE CRITICAL INCIDENTS INVOLVE 3 PATIENT DEATHS - NONE OF WHICH WERE REPORTED TO THE FDA OR ANY GLOBAL REGULATORY AGENCIES. THE EMPLOYEES AND CUSTOMERS WERE TOLD THAT ¿THE DEVICE HAS FUNCTIONED AS INTENDED¿ BUT INTERNAL INVESTIGATIONS HAVE SHOWN THAT IT IS NOT TRUE. THE RISK EVALUATION ASSOCIATED WITH THESE THREE CRITICAL INCIDENTS (AND MULTIPLE OTHER CRITICAL INCIDENTS) HAVE RESULTED IN NEW RISKS THAT ARE MODERATE TO HIGH LEVEL. THIS RISK EVALUATION HAS BEEN REVIEWED BY THE COMPANY¿S CLINICAL, QUALITY AND REGULATORY TEAM. THE COMPANY HAS NOW IMPLEMENTED DESIGN CHANGES TO MITIGATE THESE MODERATE TO HIGH LEVEL RISKS, BUT THE REGULATORY TEAM WAS INFORMED TO SIGN OFF THESE CHANGES AS ¿NON-SIGNIFICANT CHANGES¿ AND THAT THESE WERE NOT ¿NEW RISKS¿ BUT MERELY ¿UNDOCUMENTED RISKS THAT WERE NEVER SHOWN TO THE FDA DURING PREMATURE REVIEW¿. ADDITIONALLY, THE G2 PLATFORM ALLOWS FOR INTEGRATION OF THIRD PARTY DEVICES FOR USE. ONE OF THE INTEGRATED DEVICES IS A SINGLE USE BP MONITOR AND CUFF. THE COMPANY HAS DECIDED TO SELL THIS THIRD PARTY BP CUFF AND MONITOR IN VIOLATION TO ITS INTENDED USE AND HAVE TOLD CUSTOMERS THAT THIS BP CUFF AND MONITOR IS INTENDED FOR MULTIPLE USE. THE REGULATORY TEAM HAS ADVISED AGAINST THIS COURSE OF ACTION WITHOUT A PRE MARKET REVIEW BUT WAS TOLD ¿BUSINESS IS BUSINESS¿ AND THE ¿CONSULTANTS SAID IT WAS OKAY¿. THE LAST EXAMPLE IS RELATED TO MISLABELING OF THE CURRENT HEALTH PLATFORM. BEST BUY, VIA GEEK SQUAD CITY, REPROCESSES THE DEVICES TO SEND OUT TO CUSTOMERS. GSC HAS A SATELLITE SITE IN PINEVILLE, NC, WHERE REPROCESSING OCCURS. BUT AT THIS SITE, THE COMPANY DOES NOT SEND OUT DEVICES TO PATIENTS WITH PROPER LABELING. A BUSINESS DECISION WAS MADE TO TAKE OUT DEVICES IN ITS APPROVED PACKAGING WITH LABELING AND INSERT THEM INTO PLASTIC TUBS FOR ¿EASE OF TRANSPORT¿. THIS PLASTIC TUB DOES NOT HAVE THE REQUIRED PATIENT LABELING AND IS SENT OUT TO THE CUSTOMERS AND USERS WITHOUT THE RELEVANT MEDICAL DEVICE REGULATORY AND SAFETY LABELING; 2 OF THE 3 DEATHS MENTIONED ABOVE OCCURRED WITH KITS THAT WERE REPROCESSED AND SENT TO USERS WITHOUT PROPER LABELING. THE PLASTIC TUBS HAVE ALSO NOT BEEN VALIDATED AS A SAFE WAY TO TRANSPORT THESE DEVICE. THESE ARE THREE SPECIFIC INSTANCES THAT WERE MORE EGREGIOUS. HOWEVER, IN GENERAL, THE COMPANY DOES NOT HAVE PROPER DESIGN CONTROLS, AND HAVE COMMERCIALIZED PRODUCTS WITHOUT THE PROPER SAFETY TESTING, RISK ASSESSMENT, REGULATORY ASSESSMENT AND TECHNICAL DOCUMENTATION. CURRENT HEALTH WAS INSPECTED BY THE FDA IN FEBRUARY 2024, BUT THERE WERE MAJOR EFFORTS TO HIDE A LOT OF INFORMATION AND MISDIRECT THE AUDITOR. THE LEADERSHIP TEAM WERE HEARD JOKING ABOUT HOW THE INSPECTION WAS ¿FUNNY¿ AS THEY HAVE DELIBERATELY CONFUSED THE AUDITOR BY STATING THEY HAVE TECHNICAL ISSUES ON THE EQMS, THEREFORE, THEY CAN ONLY PROVIDE CERTAIN RECORDS FOR REVIEW. THE LEADERSHIP IN GENERAL HAS COMPLETE DISREGARD FOR REGULATORY AND COMPLIANCE. THE MAIN LEADER THAT MAKES THE MAJORITY OF THESE DECISIONS, (B)(4), LEADS THE QUALITY, REGULATORY, COMPLIANCE AND OPERATIONS TEAMS. DUE TO BUSINESS PRESSURE, (B)(4) ALSO PRIORITIZES DECISIONS FOR OPERATIONAL PURPOSES ONLY, ESPECIALLY WHEN THOSE DECISIONS ARE IN CONFLICT OF REGULATORY REQUIREMENTS. MANY DECISIONS HAVE BEEN MADE WITH THE MINDSET THAT THE COMPANY NEEDS TO MAKE MONEY AND KEEP CUSTOMERS HAPPY. I BELIEVE THAT (B)(4) ROLE IS A CONFLICT OF INTEREST AT THIS TIME. THIS HAS BEEN RAISED BY MULTIPLE PEOPLE TO OTHER LEADERS, BUT WERE IGNORED BECAUSE (B)(6) IS HIGHLY RESPECTED. (B)(4) IS THE VP OF QUALITY AND REGULATORY AND SHE HAS ALWAYS ALIGNED HER VIEWS WITH THE BUSINESS AND DISREGARDS REGULATORY REQUIREMENTS WHEN DECISIONS NEED TO BE MADE. I AM GETTING INCREASINGLY CONCERNED ABOUT THE PATIENTS USING THIS DEVICE. THE REGULATORY TEAM HAS RAISED THIS CONCERN TO (B)(4) AND (B)(4) BUT EMAILS AND MESSAGES WERE ALWAYS IGNORED. MANY OF THE CUSTOMERS ARE HEALTH ORGANIZATIONS LIKE (B)(6), (B)(6), THE (B)(6), AND THESE CUSTOMERS HAVE BEEN RAISING DISSATISFACTION WITH THE USE OF THE DEVISES AS WELL. I SINCERELY HOPE THE FDA REVIEWS THIS COMPLAINT TO ITS FULLEST. THANK YOU.