Description of Event or Problem · 0
(B)(6) PT WAS SHIPPED A NEW (NOT REFURBISHED) COGNOSANTE TELEHEALTH HUB DEVICE, SERIAL NUMBER: (B)(6). ANOTHER PT IN (B)(6) HAD ALREADY BEEN ISSUED A HUB WITH THE SAME SERIAL NUMBER, WHICH WAS ACTIVE AND IN USE. SERIAL NUMBERS ARE APPLIED TO THE DEVICES BY COGNOSANTE. COGNOSANTE REP RESPONSE WAS "HAVING HAD CASES LIKE THIS BEFORE, THE EASIEST SOLUTION MAY BE TO JUST FOR US TO RMA / CREDIT THE HUB THAT HAS THE DUPLICATE SN AND HAVE YOU REORDER A NEW ONE FOR THIS (B)(6)". HAVING HAD CASES LIKE THIS BEFORE? THIS IS WHAT I REPORTED TO VA LEADERSHIP: SITUATION - VENDOR (COGNOSANTE) MISLABELED THEN SHIPPED A (B)(6) HOME TELEHEALTH TABLET (MEDICAL EQUIPMENT) WITH A DUPLICATE SERIAL NUMBER. TWO SEPARATE (B)(6) (ONE IS OK, IN (B)(6)) HAD HOME MONITORING EQUIPMENT WITH IDENTICAL SERIAL NUMBERS. THIS HAD HE POTENTIAL TO MISDIRECT (B)(6) DATA. BACKGROUND / RISK FACTORS - EQUIPMENT WAS SHIPPED FROM THE VENDOR (COGNOSANTE) TO THE (B)(6). THE (B)(6) THEN SHIPPED THE DEVICE TO THE (B)(6) WHEN IT WAS ORDERED AS PART OF HIS TELEHEALTH MONITORING PACKAGE. A WRONG SERIAL NUMBER ON A MEDICAL DEVICE POSES A SIGNIFICANT RISK BECAUSE IT CAN HINDER PROPER TRACKING, RECALL MANAGEMENT, AND POTENTIALLY LEAD TO THE USE OF FAULTY OR EXPIRED DEVICES, PUTTING PT SAFETY AT RISK BY PREVENTING ACCURATE IDENTIFICATION AND ANALYSIS OF POTENTIAL ISSUES RELATED TO THAT SPECIFIC DEVICE; THIS CAN ALSO CAUSE COMPLICATIONS WITH REGULATORY COMPLIANCE DUE TO DIFFICULTY IN VERIFYING DEVICE HISTORY AND WARRANTY INFO. ASSESSMENT - THIS HAD THE POTENTIAL TO PUT A PT AT RISK. SYSTEMS IN PLACE (VENDOR ONLINE PORTAL) IDENTIFIED THAT THIS WAS A DUPLICATE SERIAL NUMBER AND WOUND NOT ALLOW THE USE / ACTIVATION OF THIS PIECE OF EQUIPMENT IN QUESTION. NO HARM WAS DONE TO OUR (B)(6). HE WILL BE SHIPPED A NEW TABLET AND BEGIN MONITORING IN THE NEAR FUTURE. RESPONSE / INTERVENTIONS - THE RESPONSE SHOULD INCLUDED: IMMEDIATELY STOPPING USE OF THE DEVICE (DONE), NOTIFYING THE MFR (DONE). IT SHOULD CONTINUE WITH INITIATING AN INVESTIGATION TO DETERMINE THE CAUSE OF THE ERROR, POTENTIALLY CONTACTING REGULATORY AUTHORITIES LIKE THE FDA DEPENDING ON THE SEVERITY AND TAKING NECESSARY CORRECTIVE ACTIONS LIKE RECALLING AFFECTED DEVICES WITH POTENTIAL INCORRECT SERIAL NUMBERS; THE PRIMARY FOCUS SHOULD BE ON PT SAFETY AND ENSURING ACCURATE TRACKING OF THE DEVICE FOR POTENTIAL RECALL SITUATIONS. I AM UNSURE IF THE DEPT OF (B)(6) SENT THIS FORM IN. I HAVE CONCERNS RELATED TO THE QUALITY CONTROL PROCEDURES IN PLACE WHICH LED TO AN EVENT LIKE THIS. IN WHAT OTHER ASPECTS OF THEIR OPERATIONS IS THIS VENDOR APPLYING THIS SAME "LEVEL OF DILIGENCE". PT WAS UNAWARE OF THE ISSUE. THE EQUIPMENT WAS NEVER FULLY ACTIVATED BY THIS PT. HE RECEIVED A REPLACEMENT UNIT AND SHIPPED ORIGINAL UNIT BACK TO THE (B)(6).