MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET, INFUSION SET

Model Number	MMT-387
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The claimed failure cannot be confirmed.No lot number reported and no device returned for investigation.
Event or Problem Description
Unomedical reference number: (b)(4).Wife reported that male diabetic patient on pump therapy has passed away.Reported infusion set tubing kinked and his blood sugars went to over 1000 mg/dl by the time he they got to hospital he was in dka and passed away shortly after.Date of hospitalization and death unknown.No further information available.

• Brand Name: QUICK-SET, INFUSION SET
• Common Device Name: QUICK-SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• MDR Report Key: 9102726
• Report Number: 3003442380-2019-00007
• Device Sequence Number: 19374386
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K991759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-387
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization