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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-943
Device Problem Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Brain Injury (2219)
Event Date 07/26/2017
Event Type  Injury  
Manufacturer Narrative
The complaint case is a legal case. Presently our information is restricted to a lawyer-authored description of the incident, see texts a) to e) below. A) "mr. (b)(6) used the minimed insulin pump with the mio infusion set to manage his type i diabetes. " b) "less than two months prior to the recall [medtronic recall reference fa-784], on (b)(6) 2017, mr. (b)(6) experienced severe hypoglycemia and suffered a seizure resulting in a traumatic brain injury due to an overdelivery of insulin caused by his malfunctioning minimed insulin pump and mio infusion set that he had been wearing at the time. " c) "in spite of the presence of multiple surveillance cameras located throughout (b)(6)'s property, more than two hours passed before the property manager discovered mr. (b)(6)'s motionless body through surveillance footage. Upon finding mr. (b)(6) unconscious and nonresponsive, he was transported emergently to (b)(6) medical center. " d) "emergency room personnel at (b)(6) medical center determined mr. (b)(6)'s brain trauma was so severe that he was flown to (b)(6) hospital in (b)(6) where he endured numerous medical and surgical procedures to keep him alive. " e) "mr. (b)(6) remains physically and mentally incapacitated due to the failure of the minimed insulin pump and mio infusion set. " the available information quoted above, texts a) to e), does not allow unomedical, at present, to provide a proper, non-speculative clinical/medical assessment. If further relevant information becomes available unomedical will submit a follow-up, supplemental mdr report to fda within 30 days after receiving such new relevant information.
 
Event Description
(b)(4). This complaint case is a legal case. Presently our information is restricted to a lawyer-authored description of the incident, see texts a) to e) below. A) "mr. (b)(6) used the minimed insulin pump with the mio infusion set to manage his type i diabetes. " b) "less than two months prior to the recall [medtronic recall reference fa-784], on (b)(6) 2017, mr. (b)(6) experienced severe hypoglycemia and suffered a seizure resulting in a traumatic brain injury due to an overdelivery of insulin caused by his malfunctioning minimed insulin pump and mio infusion set that he had been wearing at the time. " c) "in spite of the presence of multiple surveillance cameras located throughout (b)(6)'s property, more than two hours passed before the property manager discovered mr. (b)(6)'s motionless body through surveillance footage. Upon finding mr. (b)(6) unconscious and nonresponsive, he was transported emergently to (b)(6) medical center. " d) "emergency room personnel at (b)(6) medical center determined mr. (b)(6)'s brain trauma was so severe that he was flown to (b)(6) hospital in (b)(6) where he endured numerous medical and surgical procedures to keep him alive. " e) "mr. (b)(6) remains physically and mentally incapacitated due to the failure of the minimed insulin pump and mio 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 Key7849718
MDR Text Key119326741
Report Number3003442380-2018-00030
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 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-943
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 Received08/30/2018
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: 09/06/2018 Patient Sequence Number: 1
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