NovoFine® Autocover® 30G 185275Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00301691852757), received between Jul 23, 2018 and Nov 16, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2022Improper or Incorrect Procedure or Method; Wrong Label; Improper or Incorrect Procedure or Method; Wrong Label

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) HEART ATTACK [MYOCARDIAL INFARCTION]. CONGESTIVE HEART FAILURE [CARDIAC FAILURE CONGESTIVE]. DIABETES OUT OF CONTROL [DIABETES MELLITUS INADEQUATE CONTROL]. LABEL INSTRUCTIONS INDICATED THAT THE NOVOFINE 8MM (30G) AUTOCOVER NEEDLE BE USED FOUR TIMES A DAY [PRODUCT DISPENSING ERROR]. WAS PRESCRIBED TO REUSE THE AUTOCOVER NEEDLES 4 TIMES PER DAY [MULTIPLE USE OF SINGLE-USE PRODUCT]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HEART ATTACK (HEART ATTACK)" BEGINNING ON (B)(6) 2022, "CONGESTIVE HEART FAILURE(CONGESTIVE HEART FAILURE)" BEGINNING ON (B)(6) 2022, "DIABETES OUT OF CONTROL (LOSS OF CONTROL OF DIABETES)" WITH AN UNSPECIFIED ONSET DATE, "LABEL INSTRUCTIONS INDICATED THAT THE NOVOFINE 8MM (30G) AUTOCOVER NEEDLE BE USED FOUR TIMES A DAY (WRONG DIRECTIONS TYPED ON LABEL)" WITH AN UNSPECIFIED ONSET DATE, "WAS PRESCRIBED TO REUSE THE AUTOCOVER NEEDLES 4 TIMES PER DAY (NEEDLE REUSAGE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 74 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOFINE 8MM (30G) AUTOCOVER (NEEDLE) FROM 2017 FOR "DEVICE THERAPY",

  Patient problems: Heart Failure/Congestive Heart Failure; Hyperglycemia; Hypoglycemia; Myocardial Infarction

  MAUDE report 15809659 ↗
• InjuryAug 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  CASE DESCRIPTION: CONCOMITANT PRODUCTS INCLUDED - LEVEMIR FLEXPEN (INSULIN DETEMIR) SOLUTION FOR INJECTION, .0024 MOL/L, TOUJEO (INSULIN GLARGINE), LANTUS (INSULIN GLARGINE), HUMALOG (INSULIN LISPRO). ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED HYPERGLYCAEMIA AND WAS ON THE THIRD ADMISSION TO HOSPITAL FOR DIABETIC KETOACIDOSIS. THE REPORTER INFORMED THAT THE NEEDLE MIGHT BE MALFUNCTIONING AS LARGE AMOUNT OF INSULIN TRICKLES DOWN THE SKIN, BUT NO PUNCTURE WOUND WAS VISIBLE ON THE PATIENT'S SKIN DESPITE ABLE TO HEAR DEPRESS AND CLICK AND RED FLAG. PATIENT REPORTED OF USING NEW NEEDLE FOR EACH INJECTION AND WAS REMOVING THE NEEDLE FROM THE DEVICE AFTER INJECTION. ON AN UNSPECIFIED DATE, THE TYPE OF PEN NEEDLES WAS CHANGED AND THE PATIENT RECOVERED FROM THE EVENTS. ACTION TAKEN TO NOVOFINE 8MM (30G) AUTOCOVER WAS PRODUCT DISCONTINUED. THE OUTCOME FOR THE EVENT "DIABETIC KETOACIDOSIS" WAS RECOVERED. THE OUTCOME FOR THE EVENT "NEEDLE WAS MALFUNCTIONING AS LARGE AMOUNT OF INSULIN TRICKLES DOWN THE SKIN" WAS NOT REPORTED. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -NEW CONCOMITANT MEDICATIONS ADDED. -THE OUTCOME FOR THE EVENT " DIABETIC KETOACIDOSIS" WAS UPDATE

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8875206 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCIDENTAL NEEDLE STICK WITH POTENTIAL (B)(6) TRANSMISSION [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A NURSE AS "ACCIDENTAL NEEDLE STICK WITH POTENTIAL (B)(6) TRANSMISSION" BEGINNING ON (B)(6) 2019, "ACCIDENTAL NEEDLE STICK WITH POTENTIAL (B)(6) TRANSMISSION" BEGINNING ON (B)(6) 2019, AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH NOVOFINE 8MM (30G) AUTOCOVER (NEEDLE) FROM UNKNOWN START DATE DUE TO "DEVICE THERAPY". MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT PRODUCTS INCLUDED - BYETTA (EXENATIDE, EXENATIDE) ON (B)(6) 2019. THE PATIENT ACCIDENTALLY STUCK HERSELF WITH NOVOFINE AUTOCOVER NEEDLE AFTER ADMINISTERING BYETTA TO A PATIENT WITH (B)(6). THE PATIENT STUCK HERSELF WITH THE PART OF THE NEEDLE THAT WENT INTO THE BYETTA. ACTION TAKEN TO NOVOFINE 8MM (30G) AUTOCOVER WAS NOT REPORTED. BATCH NUMBER WAS REPORTED. THE OUTCOME FOR THE EVENT "ACCIDENTAL NEEDLE STICK WITH POTENTIAL (B)(6) TRANSMISSION" WAS NOT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8421894 ↗
• InjuryJul 23, 2018Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  HIGH BLOOD SUGARS [BLOOD GLUCOSE INCREASED], DOES NOT RECEIVE THE FULL DOSE WITH NOVOFINE AUTOCOVER AND NOVOLOG, FLEXPEN [INCORRECT DOSE ADMINISTERED BY DEVICE], THE COVER HAS SOME INSULIN LEFT IN IT AFTER HER DOSAGE [DEVICE LEAKAGE], BOTH HIGH AND LOW BLOOD SUGAR [BLOOD GLUCOSE FLUCTUATION]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HIGH BLOOD SUGARS" BEGINNING ON (B)(6) 2018, "DOES NOT RECEIVE THE FULL DOSE WITH NOVOFINE AUTOCOVER AND NOVOLOG FLEXPEN" BEGINNING ON (B)(6) 2018, "THE COVER HAS SOME INSULIN LEFT IN IT AFTER HER DOSAGE" BEGINNING ON (B)(6) 2018, "BOTH HIGH AND LOW BLOOD SUGAR" BEGINNING ON (B)(6) 2018, AND CONCERNED A FEMALE PATIENT WHO WAS TREATED WITH NOVOFINE 8 MM (30G) AUTOCOVER (NEEDLE) FROM (B)(6) 2018 DUE TO "TYPE 1 DIABETES MELLITUS", , NOVOLOG FLEXPEN (INSULIN ASPART) FROM 2000 AND ONGOING DUE TO "TYPE 1 DIABETES MELLITUS" (REGIMEN # 1 SLIDING SCALE, REGIMEN # 2 DOSE INCREASED). PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX NOT REPORTED. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS (DURATION UNKNOWN). TREATMENT INCLUDED INTRAVENOUS (IV) FLUIDS. IT WAS REPORTED THAT,ON AN UNKNOWN DATE IN (B)(6) 2

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7711414 ↗