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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-923
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypoglycemia (1912); Coma (2417)
Event Date 07/14/2017
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for flow, leak and ventilation to the pcc. All test results were within specifications. The batch record 5170778 was verified and found it within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and the reference samples from the same lot number. According to unomedical's traceability records, no relevant deviations were found. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). In (b)(6) 2017 a female diabetic patients experienced coma due to low blood glucose levels. A few hours after an infusion set change, the patient´s blood glucose level fell to about 35 mg/dl. 911 was called and patient was hospitalized. Patient is claiming that the cause of the event might be related to the recall fa784. Patient is not claiming any infusion set malfunctions.
 
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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
aaholmvej 1-3
osted
lejre, 4320
548167000
MDR Report Key6943401
MDR Text Key89262115
Report Number3003442380-2017-00012
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 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2019
Device Model NumberMMT-923
Device Lot Number5170778
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
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: 10/12/2017 Patient Sequence Number: 1
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