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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 06/28/2019
Event Type  Injury  
Manufacturer Narrative
Lot number is unknown. No set has been returned for investigtations. Thus no reference samples can be investigated and no batch review can be performed.
 
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. On (b)(6) 2019 he experience elevated blood glucose at 1064 mg/dl followed by coma. Patient is taken to er where he is hospitalised (lake west hospital) and is in coma for two days. Patient claims that the hyperglycemia, dka and coma is caused by the infusion set.
 
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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 Key8849595
MDR Text Key152902997
Report Number3003442380-2019-00006
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 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-941
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
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: 08/01/2019 Patient Sequence Number: 1
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