MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC BLUE

Model Number MMT-943

Device Problem Leak/Splash (1354)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced low blood glucose level and had tried to treat it with food.Patient experienced this issue for a month.Consequently, on (b)(6) 2019, the patient was admitted to the hospital due to low blood glucose level.During hospitalization, the patient received glucose intravenously and was hospitalized for at least four days.No further information available.

• Brand Name: MIO¿
• Type of Device: INSET II 60/6 PCC BLUE
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9761989
• MDR Text Key: 182727177
• Report Number: 3003442380-2020-00189
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MMT-943
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1