MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK SET PARADIGM; UNO QUICK-SET 60/9 SC1 MMUL

Model Number	MMT-397A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.The patient reported that she faced 05 infusion set cannulas were bent.She noticed that her site was leaking and then when she pulled out the infusion set and found that it was bent in an angle on(b)(6) 2024.The insertion site of the infusion site was at stomach.The blood glucose levels of patient was also very high that she vomited.She was able to bring her blood glucose levels down by using insulin pens.The patient's blood glucose level at time of incident was 26 mmol/l.Patient's current blood glucose level value (at time of call) was 5 mmol/l.The length of time infusion set has been in use was less than a day.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
Additional Manufacturer Narrative
Initial and final mdr (b)(4).Device 2 of 5.(b)(6).

• Brand Name: QUICK SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/9 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: 19446766
• Report Number: 3003442380-2024-05810
• Device Sequence Number: 3264487
• Product Code: FPA
• UDI-Device Identifier: 05705244017603
• UDI-Public: 05705244017603
• 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): 06/03/2024

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 Expiration Date: 09/01/2026
• Device Model Number: MMT-397A
• Device Lot Number: 6003957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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