MAUDE Adverse Event Report: UNOMEDICAL A/S MINIMED QUICK-SET; UNO QUICK-SET 80/9 SC1 MMUL

Model Number	MMT-386A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that patient experienced high blood glucose level 265 mg/dl, therefore, patient did a bolus through the pump and insulin leaked while doing the bolus leaked from site set was due to set changed blood glucose stayed high entire day yesterday blood glucose was at 250 mg/dl before bedtime.The high blood glucose was corrected through the pump.Now, sensor glucose level was 177 mg/dl.Also, before connecting back to set, patient always complete rewind/load reservoir process and insulin exit as well.The infusion set was used for three days.No further information was available.
Additional Manufacturer Narrative
E1: patient city -(b)(6).Patient country -(b)(6).

• Brand Name: MINIMED QUICK-SET
• Common Device Name: UNO QUICK-SET 80/9 SC1 MMUL
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19622999
• Report Number: 3003442380-2024-10699
• Device Sequence Number: 12332761
• Product Code: FPA
• UDI-Device Identifier: 05705244017849
• UDI-Public: 05705244017849
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-386A
• Device Lot Number: 6005547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown