Question

Remi, a nurse in charge of checking patient blood sugar levels, notices that all of his patient blood sugars are abnormally high. He goes back and checks them all again with a new glucose monitor, and only a few of the patients have high blood sugar this time. He tests them again with the first machine and they are all high again. What should Remi do next?
fill out a medical device report and stop using the first machine
fill out a medical device report but continue using the first machine until the report comes back
stop using the second machine
stop using the first machine

Answer 1

fill out a medical device report and stop using the first machine.

Rationale and next steps:
- The first meter is giving consistently high readings while a second, new meter does not — this indicates the first device is likely malfunctioning and poses a patient safety risk.
- Immediately take the first device out of service, label/quarantine it, remove any test strips, and notify your supervisor/biomedical engineering.
- Re-check the affected patients with a known working monitor or send samples to the lab as needed and document the correct values and actions taken.
- Complete your facility's medical device incident/adverse event report (and any required external reporting) and follow up for repair, recalibration, or replacement per policy.