• 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 MEDTRONIC QUICK-SET INFUSION SET INSULIN 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 MEDTRONIC QUICK-SET INFUSION SET INSULIN INFUSION SET Back to Search Results
Model Number MMT-397
Device Problems Material Twisted/Bent (2981); Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Coma (2417); Loss of consciousness (2418)
Event Date 06/20/2017
Event Type  Injury  
Manufacturer Narrative
Unomedical is seeking further information. At the moment it is unclear whether our infusion set was actually causally involved in the reported incident. We expect to submit a final (follow-up) mdr within a months time.
 
Event Description
Unomedical reference (b)(4). On (b)(6) 2018 medtronic informs unomedical about a historical case. A female diabetic patient is treated with insulin via a medtronic insulin pump and a quick-set insulin infusion set manufactured by unomedical. It is reported that she experience elevated blood glucose and via ems is admitted to er. Here she becomes unconscious for two days and is treated in hospital for a further three days. At hospital a bent soft cannula is noticed. There is no data regarding the pump issuing no delivery alarm(s). Patient remains off pump and will not go back to pump therapy until she gets a new medtronic pump.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDTRONIC QUICK-SET INFUSION SET
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 Key8132271
MDR Text Key129297458
Report Number3003442380-2018-00033
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K106648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
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: 12/05/2018 Patient Sequence Number: 1
-
-