MAUDE Adverse Event Report: UNOMEDICAL A/S SURE T

Model Number	MMT-864
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Coma (2417)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SURE T
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• MDR Report Key: 11121616
• Report Number: 3003442380-2021-00001
• Device Sequence Number: 11867694
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041545
• 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): 01/05/2021

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 Expiration Date: 07/01/2022
• Device Model Number: MMT-864
• Device Lot Number: 5285757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/05/2021
• 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: Hospitalization; Life Threatening