NovoFine® Plus 32G 185850Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00301691858506), received between Mar 28, 2022 and May 23, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS), NEEDLE REUSAGE [MULTIPLE USE OF SINGLE-USE PRODUCT], LEFT LEG INFECTION [LOCALISED INFECTION], POSSIBLE BLOOD CLOTTING [THROMBOSIS]. CASE DESCRIPTION: STUDY ID: PATIENT ASSISTANCE PROGRAM STUDY DESCRIPTION: THE NOVO NORDISK DIABETES PATIENT ASSISTANCE PROGRAM IS A PROGRAM FOR PATIENTS THAT QUALIFY FOR FINANCIAL ASSISTANCE PURSUANT TO FINANCIAL GUIDELINES AS ESTABLISHED BY NOVO NORDISK. PATIENTS WILL BE EVALUATED FOR THE PROGRAM AGAINST THE CRITERIA ESTABLISHED BY NOVO NORDISK. THIS SERIOUS SOLICITED REPORT FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NEEDLE REUSAGE(NEEDLE REUSAGE)" WITH AN UNSPECIFIED ONSET DATE , "LEFT LEG INFECTION(LEG INFECTION)" WITH AN UNSPECIFIED ONSET DATE , "POSSIBLE BLOOD CLOTTING(CLOT BLOOD)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A MALE PATIENT (BORN IN 1953) WHO WAS TREATED WITH NOVOFINE 32G 4MM (NEEDLE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS". CURRENT CONDITION: DIABETES (TYPE AND DURATION WAS NOT REPORTED). CONCOMITANT MEDICATIONS INCLUDED - TRESIBA FLEXTOUCH U100(INSULIN DEGLUDEC 100 IU/ML) SOLUTION FOR INJECTION, 100 IU/ML, TRESIBA FLEXTOUCH U200(IN

  Patient problems: Administration Site Reaction; Local Reaction

  MAUDE report 14476042 ↗
• InjuryMar 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  EVENT VERBATIM. NEEDLE REUSAGE; MULTIPLE USE OF SINGLE-USE PRODUCT. LEFT LEG INFECTION; LOCALISED INFECTION. POSSIBLE BLOOD CLOTTING, THROMBOSIS. CASE DESCRIPTION: STUDY ID: PATIENT ASSISTANCE PROGRAM. STUDY DESCRIPTION: THE NOVO NORDISK DIABETES PATIENT ASSISTANCE PROGRAM IS A PROGRAM FOR PATIENTS THAT QUALIFY FOR FINANCIAL ASSISTANCE PURSUANT TO FINANCIAL GUIDELINES AS ESTABLISHED BY NOVO NORDISK. PATIENTS WILL BE EVALUATED FOR THE PROGRAM AGAINST THE CRITERIA ESTABLISHED BY NOVO NORDISK. THIS SERIOUS SOLICITED REPORT FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NEEDLE REUSAGE(NEEDLE REUSAGE)" WITH AN UNSPECIFIED ONSET DATE , "POSSIBLE BLOOD CLOTTING(CLOT BLOOD)" WITH AN UNSPECIFIED ONSET DATE , "LEFT LEG INFECTION(LEG INFECTION)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A MALE PATIENT (BORN IN 1953) WHO WAS TREATED WITH NOVOFINE 32G 4MM (NEEDLE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS". CURRENT CONDITION: DIABETES (TYPE AND DURATION WAS NOT REPORTED). CONCOMITANT MEDICATIONS INCLUDED - TRESIBA FLEXTOUCH U100(INSULIN DEGLUDEC 100 IU/ML). SOLUTION FOR INJECTION, 100 IU/ML. ON AN UNSPECIFIED DATE, THE PATIENT REPORTED OF REUSING THE NEEDLES. AS A RESULT THE PATI

  Patient problems: Administration Site Reaction; Local Reaction

  MAUDE report 13927448 ↗