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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 Appropriate Term/Code Not Available (3191)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Coma (2417)
Event Date 06/18/2017
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 5177291 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. Since patients mother had doubts about which of two lot numbers patient was using at the time of the event, two similar mdrs have been created: 3003442380-2017-00013 and 3003442380-2017-0014.
 
Event Description
Unomedical reference number (b)(4). In (b)(6) 2017 a female diabetic patient experienced low blood glucose levels and she tried to treat with juice. The patient was found two days later in coma with her pump disconnected from her body. By that time her blood sugar was 1600 mg/dl and her body temperature was 89, ph 6. 9. Her kidneys had shut down and the fluid depressed her heart function. She also suffered deep tissue wounds due to being down for so long. She was in a coma for 18 days, intubated and on dialysis. She remained in intensive care for nearly a month before spending a month at a neuro rehab facility. Patient was not claiming any 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 Key6978950
MDR Text Key90287195
Report Number3003442380-2017-00014
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 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2020
Device Model NumberMMT-943
Device Lot Number5177291
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
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: 10/26/2017 Patient Sequence Number: 1
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