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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO UNO INSET II 80/9 SC1 GREY MIMX

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MIO UNO INSET II 80/9 SC1 GREY MIMX Back to Search Results
Lot Number UNKNOWN
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2021, it was reported that the patient's infusion set's tubing detached at the quick release while sleeping. The site location was right side of her abdomen and the pump was on the same side clipped to the top of pants toward the hip area. The infusion set had been used for two days. The infusion sets were stored in a box in a plastic tub. Currently, her blood glucose level was 327 mg/dl. Upon visual inspection of the returned used device (one set), it showed that the tubing was detached from the tubing connector. No further information available.
 
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Brand NameMIO
Type of DeviceUNO INSET II 80/9 SC1 GREY MIMX
MDR Report Key12603810
MDR Text Key276114681
Report Number3003442380-2021-00547
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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