contact detach 100-905-02Recalls & 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
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244006171), received between Apr 9, 2019 and Apr 9, 2019 — classified as 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
Patient problems
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT HER INFUSION SET'S TUBING CRACKED/ BROKE. SHE STATED THAT WHEN SHE WENT TO CHANGE, SHE NOTICED THAT THE LINE BETWEEN THE ANCHOR AND THE INFUSION SET HAD BROKEN OFF, WHERE IT WAS ATTACHED TO THE INFUSION SET. REPORTEDLY, SHE EXPERIENCED POLYDIPSIA, HER BLOOD GLUCOSE LEVEL WAS 17.3 MMOL/L AND THE LEVEL OF KETONES WAS AT 1.4 MMOL/L AT THAT TIME. SHE HAD SET THE TEMPORARY BASAL TO +30% FOR THE TREATMENT AND REMAINED ON THE PUMP. AFTER SHE RECEIVED THE TREATMENT, HER CONDITION IMPROVED WITH BLOOD GLUCOSE LEVEL OF 7.7 MMOL/L AND SHE WAS SYMPTOM FREE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8494363 ↗
Other Set, Administration, Intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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