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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S MEDTRONIC MIO INSULIN INFUSION SET Back to Search Results
Model Number MMT-975
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 03/19/2018
Event Type  Death  
Manufacturer Narrative
The available case data does not indicate causal relation between death and any possible infusion set failure. No further information is expected to become available.
 
Event Description
(b)(4). An estranged wife calls medtronic helpline to informed that her husband passed away at home on (b)(6) 2018. It is not known if the husband was using insulin pump at time of death. Reporting person believes that cause of death was diabetic coma. Infusion set was a medtronic mio, model mmt-975 of unknown lot number. Further information is not provided and is not expected to become available.
 
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Brand NameMEDTRONIC MIO
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 Key7618385
MDR Text Key111632763
Report Number3003442380-2018-00024
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 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-975
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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