• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MIO INSULIN PUMP INFUSION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNOMEDICAL A/S MIO INSULIN PUMP INFUSION SET Back to Search Results
Model Number MMT-941600
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Diabetic Ketoacidosis (2364)
Event Date 05/24/2018
Event Type  Death  
Manufacturer Narrative
The stated many set changes during 3-4 days may indicate patient having problems with either the infusion sets or having pump problems (i. E. The constant pump alarms resulted in the patient having removed his pump). Data does not allow making proper assessment of causal relationship between pump/dka and/or infusion set/dka.
 
Event Description
(b)(4). (b)(6). A widow reports to medtronic helpline that her husband passed away on (b)(6) 2018 after being admitted to hospital on (b)(6) 2018 with diabetic ketoacidosis (dka). Reportedly, physicians state cause of death as severe dka. It is reported that blood glucose (bg) had been high for the previous couple of days. A roommate informed that the pump was constantly alarming so the patient therefore removed the pump. It is reported that the patient for 3-4 days performed multiple daily (site/set) changes. No further information is available or expected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMIO
Type of DeviceINSULIN PUMP 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 Key7662262
MDR Text Key113154547
Report Number3003442380-2018-00028
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 07/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-941600
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/04/2018
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: 07/04/2018 Patient Sequence Number: 1
-
-