STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Additional Manufacturer Narrative

THIS INVESTIGATION WAS CONDUCTED IN RESPONSE TO CUSTOMER COMPLAINT (B)(4), IN WHICH THE CUSTOMER REPORTED THAT THEIR STATSTRIP GLU HOSPITAL 2.0 WIRELESS METER AND STATSTRIP 2.0 WIRELESS DOCKING STATION WERE DAMAGED DUE TO OVERHEATING, RESULTING IN MELTED PLASTIC. THE RETURNED DEVICES INCLUDED A STATSTRIP GLU HOSPITAL 2.0 WIRELESS METER (SN (B)(6)) AND STATSTRIP 2.0 WIRELESS DOCKING STATION (SN (B)(6)). UPON RECEIPT, BASIC POWER-UP TESTING CONFIRMED THAT THE METER POWERED ON SUCCESSFULLY AND WAS ABLE TO CHARGE IN THE RETURNED DOCKING STATION WITHOUT ISSUE. VISUAL INSPECTION IDENTIFIED LOCALIZED MELTING OF THE EXTERNAL PLASTIC HOUSING ON THE BACK OF THE METER AND THE FRONT OF THE WIRELESS DOCKING STATION AT THE INTERFACE WHERE THE DEVICES CONNECT DURING NORMAL WIRELESS CHARGING (REFER TO ATTACHMENT 1, IMAGES 1 AND 2). IT WAS NOTED THAT THE AFFECTED AREAS EXHIBITED A DISTINCT WAFFLE-PATTERN IMPRINT AND THE PRESENCE OF AN ORANGE/YELLOW RESIDUE OF UNKNOWN ORIGIN. THE IMPACTED HOUSING COMPONENTS WERE REMOVED TO FACILITATE INTERNAL INSPECTION. MINIMAL IMPACT TO INTERNAL COMPONENTS WAS OBSERVED, INDICATING THE SOURCE OF THE DAMAGE LIKELY ORIGINATED EXTERNALLY TO THE DEVICES. THE CUSTOMER WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE OBSERVED ORANGE/YELLOW RESIDUE AND WAFFLE PATTERN, BUT THEY DENIED KNOWLEDGE OF ANY FOREIGN MATERIAL OR CONTRIBUTING CONDITIONS. TO FURTHER EVALUATE THE OBSERVED RESIDUE, MATERIAL SAMPLES FROM THE RETURNED METER AND DOCKING STATION WERE SUBMITTED FOR EXTERNAL ANALYSIS BY ANALYTICAL ANSWER. ANALYTICAL RESULTS IDENTIFIED THE ORANGE/YELLOW MATERIAL AS A CELLULOSE-BASED SUBSTANCE CONTAINING CALCIUM CARBONATE FILLER, SILICA/SILICATES, TITANIUM, AND A POLYMERIC BINDER, CONSISTENT WITH COATED OR GLOSSY PAPER MATERIALS SUCH AS LABELS OR PRINTED MEDIA. WHILE THE SOURCE OF THE RESIDUE AND WAFFLE PATTERN IMPRINT IS UNKNOWN, THESE FINDINGS CONFIRM THAT THEY DID NOT ORIGINATE FROM THE NOVA DEVICES AND SUPPORT THE PRESENCE OF EXTERNAL MATERIAL AT THE DEVICE INTERFACE. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR BOTH THE METER AND WIRELESS DOCKING STATION. THE DHRS WERE COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCTS MET SPECIFICATION PRIOR TO RELEASE. ADDITIONALLY, NO ISSUES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE EVIDENCE. HOWEVER, BASED ON THE INVESTIGATION FINDINGS, THE SUSPECTED ROOT CAUSE IS THAT AN UNKNOWN MATERIAL, LIKELY CUSTOMER-APPLIED LABELING, WAS PRESENT BETWEEN THE METER AND WIRELESS DOCKING STATION DURING CHARGING. THE OBSERVED WAFFLE PATTERN IMPRINT AND ORANGE/YELLOW RESIDUE ARE CONSISTENT WITH THE PRESENCE OF A FOREIGN MATERIAL AT THE DEVICE INTERFACE. THIS MATERIAL WAS LIKELY ENERGIZED DURING THE ENERGY TRANSFER BETWEEN THE TRANSMIT COIL ON THE WIRELESS DOCKING STATION AND RECEIVING COIL ON THE METER WHICH RESULTED IN LOCALIZED HEATING AND MELTING OF THE EXTERNAL PLASTIC HOUSING. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Description of Event or Problem

THE METER AND THE DOCKING STATION SHOWED EVIDENCE OF OVERHEATING. THE PLASTIC ON THE BACK OF THE METER AND AREA ON THE FRONT OF THE DOCKING STATION SHOWED EVIDENCE OF MELTING.