Varisoft™ 1000284Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244014695), received between Feb 3, 2019 and Aug 10, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 16, 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.

• MalfunctionAug 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THREE TIMES IN THE PAST THREE WEEKS, WHEN SHE INSERTED A NEW CARTRIDGE AND INFUSION SET, EVERYTHING SEEMED FINE. THEN WITHIN 4-24 HOURS, SHE NOTICED THAT THE INFUSION SET'S TUBING BROKE AWAY FROM THE CLIP THAT IS INSERTED INTO THE CANNULA. THEREFORE, FIRST EVENT OCCURRED ON (B)(6) 2020, SECOND AND THIRD EVENT ON (B)(6) 2020, RESPECTIVELY. SHE DID NOT NOTICE ANY DAMAGE TO THE INFUSION SETS WHEN THE PACKAGE WAS FIRST OPENED. MOREOVER, THE PATIENT WAS USING HUMALOG INSULIN TYPE. FURTHER, SHE REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10383900 ↗
• InjuryMay 1, 2019Device Handling Problem; Device Handling Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET WAS NOT PROPERLY INSERTED AS CANNULA OF INFUSION SET WAS NOT INSERTED PROPERLY INTO THE SKIN WHICH RESULTED IN HIGH BLOOD GLUCOSE LEVEL (497 MG/DL). THE PATIENT SELF-TREATED HIMSELF WITH MULTIPLE DOSE INJECTION AND PATIENT'S WIFE DROVE HIM TO THE HOSPITAL BECAUSE HE WAS NAUSEATED AND COULD NOT DRIVE ON HIS OWN. HE WAS IN THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE LEVEL OF 497 MG/DL, RECEIVED INSULIN AS CORRECTIVE TREATMENT AND STAYED THERE FOR ONE HOUR. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVEL OF 260 MG/DL AND WAS BETTER BUT STILL NAUSEOUS. HE RECEIVED INSULIN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8567712 ↗
• MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE TUBING SEPARATED (NOT DISCONNECTED BUT BROKE OFF) AT THE SITE ON HIS INFUSION SET. HE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494757 ↗
• MalfunctionFeb 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED, THE TUBING WAS DISCONNECTED FROM SITE. PATIENT STATED THAT SHE FIRST STARTED HAVING ISSUES WITH THE INFUSION SETS ABOUT A WEEK AGO. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8300456 ↗