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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MIO INSET LL

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UNOMEDICAL A/S MIO INSET LL Back to Search Results
Model Number MMT-943
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hypoglycemia (1912)
Event Date 09/09/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). No further information available at this time, unomedical is investigating further information. A follow-up will be submitted no later than 07/05/2018.
 
Event Description
(b)(4). (b)(6). Patient deceased saturday (b)(6) 2017 in (b)(6), probably for hypoglycemia event. No further information available at this time, unomedical is investigating further information.
 
Manufacturer Narrative
No relevant testing could be performed. If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.   the claimed failure cannot be confirmed. The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.
 
Event Description
(b)(4). (b)(6). Patient deceased saturday (b)(6) 2017 in (b)(6), probably for hypoglycemia event. No further information available.
 
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Brand NameMIO
Type of DeviceINSET LL
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
aalholmvej 1-3
osted
lejre, 4320
MDR Report Key7577023
MDR Text Key110323997
Report Number3003442380-2018-00022
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,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-943
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/09/2018
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: 06/07/2018 Patient Sequence Number: 1
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