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

Model Number MMT-387

Device Problem Material Twisted/Bent (2981)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The claimed failure cannot be confirmed.No lot number reported and no device returned for investigation.

Event 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
• Type of Device: QUICK-SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9102726
• MDR Text Key: 159569082
• Report Number: 3003442380-2019-00007
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-387
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization