Silhouette® Paradigm® MMT-382600Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
All models of Silhouette Paradigm (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244009141), received between Aug 25, 2020 and Dec 8, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Loss of or Failure to Bond1
Patient problems
- Elevated Ketones/ Diabetic Ketoacidosis1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TAPE HAD DETACHED BEFORE HOSPITALIZATION. FURTHER, THE PRODUCT WAS NOT ADHERING BECAUSE THE PATIENT LEFT THE SET FOR TOO LONG. AT THE TIME OF THE INCIDENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 20 MMOL/L, HAD KETONES AND LOW HEART RATE WHICH THE PATIENT TRIED TO TREAT IT WITH NEEDLES. THE INFUSION WAS CHANGED ON (B)(6) 2020. CONSEQUENTLY, ON (B)(6) 2020 THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND LOW HEARTBEAT FOR WHICH INJECTIONS AND PACEMAKER WAS INSTALLED AS CORRECTIVE TREATMENT. REPORTEDLY, (B)(6) 2020 THE PATIENT WAS RELEASED FROM THE HOSPITAL. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 8.0 MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 10973127 ↗MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION SET'S TUBING GOT DISCONNECTED WHILE THE PATIENT WAS SLEEPING. THE PATIENT OFTEN ROTATES WHILE SLEEPING. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON RIGHT SIDE. MOREOVER, THE INFUSION HAD BEEN USED FOR LESS THAN 24 HOURS. REPORTEDLY, THE INFUSIONS WERE STORED IN ROOM TEMPERATURE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10447357 ↗
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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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