NovoFine® Autocover® 30G 185297Recalls & reported problems
Novo Nordisk Inc. · NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00301691852979), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Flow or Under Infusion1
Patient problems
- Hyperglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). HIGH BLOOD SUGAR [BLOOD GLUCOSE INCREASED]. NOVOFINE 30 AUTOCOVER NEEDLES NOT RELEASING ENOUGH INSULIN [INCORRECT DOSE ADMINISTERED BY DEVICE]. NOVOFINE 30 AUTOCOVER NEEDLES NOT RELEASING ENOUGH INSULIN [DEVICE ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HIGH BLOOD SUGAR" BEGINNING ON (B)(6) 2018, "NOVOFINE 30 AUTOCOVER NEEDLES NOT RELEASING ENOUGH INSULIN" WITH AN UNSPECIFIED ONSET DATE, NOVOFINE 30 AUTOCOVER NEEDLES NOT RELEASING ENOUGH INSULIN" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A FEMALE PATIENT (AGE NOT REPORTED) WHO WAS TREATED WITH NOVOFINE 8MM (30G) AUTOCOVER (NEEDLE) FROM UNKNOWN START DATE DUE TO "DEVICE THERAPY", A NON-NOVO NORDISK SUSPECT PRODUCT LANTUS (INSULIN GLARGINE) FROM AN UNKNOWN START DATE DUE TO AN UNKNOWN INDICATION (DOSE AND FREQUENCY UNKNOWN). PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WAS NOT REPORTED. MEDICAL HISTORY WAS NOT PROVIDED. THE PATIENT USUALLY USED NOVOFINE 30G NEEDLES. ON AN UNKNOWN DATE, THE PATIENT STARTED USING NOVOFINE 8MM (30G) AUTOCOVER. IT WAS REPORTED THAT NOVOFINE 30 AUTOCOVER NEED
Patient problems: Hyperglycemia
MAUDE report 7873930 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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