STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY BASED ON THE INFORMATION PROVIDED AND A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. PLEASE SEE REPORT 1219029-2020-00053.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE STATSTRIP WIRELESS METER (1.75) S/N: (B)(4) HAD BEEN SITTING IN THE DOCKING STATION S/N:(B)(4) FOR APPROXIMATELY ONE WEEK. WHEN THE METER WAS REMOVED FROM THE DOCKING STATION, THERE WAS A SMALL PUFF OF BLACK SMOKE, THE PLASTIC CASE WAS SLIGHTLY MELTED AND THE CONNECTION PINS APPEARED RED. THE BATTERY WAS REMOVED AND THE DOCKING STATION UNPLUGGED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. THIS IS REPORT 2 OF 2.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THEY OBSERVED A STATSTRIP GLUCOSE METER, S/N: (B)(6), DOCKED IN THEIR DOCKING STATION, S/N: (B)(6), WITH THE SCREEN OFF WHILE THE OTHER THREE (3) DOCKED METERS WERE ON. THE CUSTOMER REMOVED THE SUBJECT METER FROM THE DOCKING STATION AND OBSERVED A SMALL PUFF OF BLACK SMOKE. THE CUSTOMER INDICATED THAT THE PLASTIC HOUSING OF THE METER WAS SLIGHTLY MELTED, AND THE CONNECTION PINS APPEARED RED. THE CUSTOMER REMOVED THE BATTERY FROM THE METER AND UNPLUGGED THE DOCKING STATION. THE FACILITY CONFIRMED THAT THE OTHER (3) METERS IN THE DOCKING STATION WERE NOT AFFECTED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. THE METER AND THE DOCKING STATION WERE RETURNED TO NOVA BIOMEDICAL FOR EVALUATION. DEVICE HISTORY RECORD (DHR) REVIEWS FOR THE METER AND DOCKING STATION WERE PERFORMED BY A NOVA QUALITY ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE PRODUCTS. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHRS INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE DOCK HAD TWO (2) METER SLOTS WITH EVIDENCE OF OVERHEATING. IT IS LIKELY THAT THE METER WAS IN DOCK #2 FOR A SHORT TIME AND THEN MOVED TO DOCK #3 AFTER CUSTOMER USE. THE DOCKING STATION COVER WAS REMOVED AND THERE WAS VISIBLE DAMAGE ON ONE OF THE BOARDS REFERRED TO AS THE ADAPTER BOARD, HOWEVER; THERE WAS NO DAMAGE TO ANY OF THE OTHER BOARDS. THE METER WAS INSPECTED, AND OVERHEATING WAS OBSERVED ON THE BOTTOM OF THE METER AND DOCKING CONNECTOR. THE DOCKING CONNECTOR IS LOCATED AT THE BOTTOM OF THE METER WHEN THE METER IS PLACED INTO THE DOCKING STATION. THE CONNECTOR HAD A LOCALIZED BURN MARK INDICATING OVERHEATING DUE TO AN ELECTRICAL SHORT. UPON FURTHER EVALUATION, FIBROUS MATERIAL WAS FOUND INSIDE THE METER DOCKING CONNECTOR. THE ROOT CAUSE WAS DETERMINED TO BE THE FIBROUS MATERIAL THAT IS MOST LIKELY A PIECE OF WET DISINFECTANT WIPE THAT BECAME LODGED INSIDE OF THE METER DOCKING CONNECTOR WHEN THE CUSTOMER PERFORMED CLEANING AND DISINFECTION OF THE METER AFTER USE. THE FIBROUS MATERIAL IS LIKELY TO HAVE SHORTED A VOLTAGE LINE TO THE GROUND CAUSING THE OVERHEATING. IT IS ALSO POSSIBLE THAT EXCESS CLEANING/DISINFECTION SOLUTION ON THE METER SURFACE, THAT IS NOT ALLOWED TO THOROUGHLY DRY, MAY HAVE BEEN EXPOSED TO THE ELECTRICAL CHARGING CONTACTS. ATTACHED PLEASE FIND THE CURRENT CLEANING AND DISINFECTION STEPS IN THE STATSTRIP GLUCOSE HOSPITAL METER SYSTEM INSTRUCTIONS FOR USE (IFU). AT THE END OF THE LABELING SECTION, THE FOLLOWING STATEMENT IS INCLUDED UNDER ADDITIONAL INFORMATION; DO NOT ALLOW LIQUID TO ENTER THE STRIP PORT CONNECTOR OR ALLOW POOLING OF LIQUID ON THE TOUCH SCREEN. IF LIQUID DOES GET INTO THE STRIP PORT OR CONNECTOR, IMMEDIATELY DRY THE COMPONENTS WITH A DRY CLOTH OR GAUZE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. PLEASE SEE REPORT 1219029-2020-00053. UDI (B)(4).