Today, Dexcom issued a press release to expand the customer notification first mentioned in passing on the company’s 4Q15 call in February: some G4 and G5 receivers’ speakers may malfunction and not sound an audible alarm or alert. That’s obviously sub-optimal if people can’t hear their alarms! The FDA specifically asked Dexcom to issue a press release – in addition to the customer notification mailed in February – and the Agency has now posted an accompanying Class I recall notice. It’s unclear how many receivers are actually affected, though all G4 and G5 receiver models and lots have been recalled, and Dexcom will send patients a free replacement receiver if the audible alerts are not working (testing instructions here). The 4Q15 call devoted one sentence to this issue in the financial discussion, presumably because few receivers were impacted at the time. Perhaps the issue has risen to a more material level at this point, and we would expect to hear more discussion on the 1Q16 call. This news is a definite safety concern to patients and we’re glad to see Dexcom has issued a formal press release, giving it much more attention than a customer notification alone – that said, most patients don’t read press releases so we hope Dexcom also uses social media to reach patients. The G4 receiver has always had some durability issues (e.g., the micro-USB port caving in), and we look forward to the updated touchscreen receiver expected to launch later this year – in the pipeline part of the 4Q15 call, management said the new receiver will be more durable. Good news for patients! We do wonder what percentage of Dexcom users use the G5 smartphone app vs. dedicated receiver – both have advantages and disadvantages, though we’re big fans of the updated G5 app.
-- by Adam Brown and Kelly Close