InPen Smart Insulin Delivery SystemRecalls & reported problems across all models

We found 5 models of InPen Smart Insulin Delivery System by Companion Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2020 and Jul 19, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Low Readings” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

InPen Smart Insulin Delivery System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 8, 2022Open, Classified

   Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.

   Z-0741-2023 · Root cause: Software design · names 5 of these models · Recall details · FDA record ↗

Most reported InPen Smart Insulin Delivery System problems

InPen Smart Insulin Delivery System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• InPen Smart Insulin Delivery System Lilly - Blue

  Syringe, Piston
  1 recall1 report
• InPen Smart Insulin Delivery System Novo - Blue

  Syringe, Piston
  1 recall1 report
• InPen Smart Insulin Delivery System Lilly - Grey

  Syringe, Piston
  1 recall0 reports
• InPen Smart Insulin Delivery System Lilly - Pink

  Syringe, Piston
  1 recall0 reports
• InPen Smart Insulin Delivery System Novo - Pink

  Syringe, Piston
  1 recall0 reports

Recent InPen Smart Insulin Delivery System adverse event reports

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

• InjuryJul 19, 2022Patient-Device Incompatibility

  HCP LEA STATED PATIENT RECEIVED THE WRONG PEN; PATIENT CANNOT USE THE DEVICE FOR HIS INSULIN AND IT IS NOT WHAT WAS ORDERED BY THE HCP. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066926 ↗
• InjuryJul 20, 2020Low Readings; Low Readings

  IT WAS REPORTED THAT A DISCREPANCY OCCURRED BETWEEN THE SELECTED DOSE AMOUNT AND (B)(6) LOGBOOK AMOUNT. ON (B)(6) 2020, THE PATIENT DOSED 5.5 UNITS OF INSULIN, HOWEVER THE LOGBOOK DISPLAYED 1.0 UNIT. THE PATIENT DOSED AN ADDITIONAL 4.5 UNITS OF INSULIN TO ACCOMMODATE THE DISCREPANCY. CONSEQUENTLY, THE PATIENT'S BLOOD GLUCOSE LEVELS DROPPED TO 37 MG/DL. THE PATIENT DRANK JUICE AND INJECTED GLUCAGON TO RAISE HER BLOOD GLUCOSE LEVELS. PROFESSIONAL MEDICAL ATTENTION WAS NOT REQUESTED BY THE PATIENT. THIS INPEN WAS NOT RETURNED, SO AN INVESTIGATION WAS NOT POSSIBLE AND A ROOT CAUSE COULD NOT BE DETERMINED. CLOUD DATA WAS REVIEWED AND SUPPORTED CUSTOMER ALLEGATION, HOWEVER A ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 10296191 ↗