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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-945
Device Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Date 03/18/2021
Event Type  Injury  
Manufacturer Narrative
N/a.
 
Event Description
Unomedical reference: (b)(4). A diabetic is treated with insulin via a medtronic insulin pump and a medtronic minimed mio blue mmt-945 infusion set. The infusion set is manufactured by unomedical a/s. On (b)(6) 2021 the patient experience elevated blood glucose at 1200 mg/dl followed by a fall and concussion, patient calls ems and then experience coma. Patient is taken to er where he is hospitalised at grove city hospital and was in coma for six days. Patient claims that the hyperglycemia and the fall is caused by the infusion set which unknowingly detached. At the medtronic helpdesk the suggested troubleshooting regarding the detachment is declined by the patient. Duration of the use of the infusion set in question is unknown to the patient. Lot/batch number is unknown. No further details are available. Causality, in particular to the coma, remains somewhat unclear.
 
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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 Key11811724
MDR Text Key250186002
Report Number3003442380-2021-00002
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 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-945
Device Lot NumberUNKNOWN
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 Received04/12/2021
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: 05/12/2021 Patient Sequence Number: 1
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