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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S MIO INFUSION SET Back to Search Results
Model Number MMT-941
Device Problem No Apparent Adverse Event (3189)
Patient Problems Death (1802); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 07/10/2016
Event Type  Death  
Manufacturer Narrative
On (b)(6) 2016 clinical evaluation: wife of a male diabetic patient contacts medtronic's helpdesk to inform that her husband passed away 2 months earlier after being hospitalised following a day of rising blood glucose level ending with diabetic ketoacidosis. Patient remained on pump therapy in hospital until death one day later when blood glucose was recorded at 33 mmol/l. Wife informs that her husband was recently diagnosed with multiple sclerosis. Wife does not allege any malfunctions of insulin pump and/or infusion set related to the death of her husband. Insulin pump and infusion set remained at hospital, thus no pump history nor examination of infusion set is available/possible. With the presently available information, it is not possible to perform a proper clinical evaluation. Should further, relevant information become available, unomedical will re-open the case and inform, by follow-up reports, the (b)(6) and the us fda as appropriate.
 
Event Description
(b)(4) - case concerns a (b)(6) citizen and occurred in the (b)(6). Wife of a male diabetic patient contacts medtronic's helpdesk to inform that her husband passed away 2 months earlier after being hospitalised following a day of rising blood glucose level ending with diabetic ketoacidosis. Patient remained on pump therapy in hospital until death one day later when blood glucose was recorded at 33 mmol/l. Wife informs that her husband was recently diagnosed with multiple sclerosis. Wife does not allege any malfunctions of insulin pump and/or infusion set related to the death of her husband.
 
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Brand NameMIO INFUSION SET
Type of DeviceINFUSION 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
548167000
MDR Report Key5969425
MDR Text Key55313102
Report Number3003442380-2016-00014
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 09/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2019
Device Model NumberMMT-941
Device Lot Number5141601
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2016
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: 09/22/2016 Patient Sequence Number: 1
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