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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MIO INSULIN INFUSION SET

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UNOMEDICAL A/S MIO INSULIN INFUSION SET Back to Search Results
Model Number MMT-941
Device Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Date 05/21/2019
Event Type  Injury  
Manufacturer Narrative
Infusion set lot 5251213 reference samples have been investigated to be fully within specifications. Batch review has been performed and are within specifications.
 
Event Description
Unomedical reference: (b)(4). A male diabetic is treated with insulin via a medtronic insulin pump and a medtronic mio paradigm mmt-941 infusion set. He also uses a cgm sensor/transmitter. Note: he is new to pump and to cgms therapy. On (b)(6) 2019 he experience elevated blood glucose at 400 mg/dl followed by seizure. Ems takes patient to a hospital ((b)(6) hospital) where he is in coma for three days and remain hospitalized for two weeks. There are no data indicating any pump failure, infusion set failure or sensor/transmitter failure. In early june it is stated, that patient 'is still working with his physician to be more aggressive with his pump settings'.
 
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Brand NameMIO
Type of DeviceINSULIN INFUSION SET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3, osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3, osted
lejre, 4320
MDR Report Key8792538
MDR Text Key151119968
Report Number3003442380-2019-00005
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2021
Device Model NumberMMT-941
Device Lot Number5251213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/16/2019 Patient Sequence Number: 1
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