MAUDE Adverse Event Report: UNOMEDICAL A/S SURE T

Model Number MMT-864

Device Problem Fluid/Blood Leak (1250)

Patient Problem Coma (2417)

Event Type  Injury  

Manufacturer Narrative

The reference samples were visually inspected and tested for flow and leak.And all were found within specifications.The batch record #: (b)(4) was verified and found it within specifications.The claim failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference sample from the same number.According to unomedical traceability record, no relevant deviation were found.If new information become available, the complaint will be re-opened and appropriate action will be taken.

Event Description

Unomedical reference number: (b)(4).A diabetic female patient reported that the infusion set was leaking on site and not delivering insulin and she went into a coma and was hospitalized.Patient had leaks in her site, especially when she does a bolus.Patient stated that there was not any stress or pull on the infusion set tubing.Patient was able to change the infusion set.Therapy at hospital is unknown.Date of incident is unknown.No further information is available.

• Brand Name: SURE T
• Type of Device: SURE T
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICA A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11121616
• MDR Text Key: 225290172
• Report Number: 3003442380-2021-00001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041545
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Model Number: MMT-864
• Device Lot Number: 5285757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening