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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC QUICK-SET INFUSION SET; INSULIN INFUSION SET

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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.
 
Event Description
Unomedical reference 1123005 - (medtronic ref svn 309096921) 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 theray until she gets a new medtronic pump.
 
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.(b)(6) 2019: unomedical is still seeking more information on this case.We will submit a final emdr within the next 30 days.We have added the medtronic reference to sec b5 (describe event or problem).(b)(6) 2019: unomedical has not been able to obtain further relevant information.It remains unclear whether our infusion set was actually causally involved in the reported incident.We close the case now.Should new relevant information become available, we will re-open the case and submit new information to fda by means of a follow-up mdr report.
 
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.18-jan-2019: unomedical is still seeking more information on this case.We will submit a final emdr within the next 30 days.We have added the the medtronic reference to sec b5 (describe event or problem).
 
Event Description
Unomedical reference (b)(4).- (medtronic ref svn (b)(4).) on 08-nov-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 theray until she gets a new medtronic pump.
 
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Brand Name
MEDTRONIC QUICK-SET INFUSION SET
Type of Device
INSULIN INFUSION SET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3, osted
lejre, 4320
DA  4320
MDR Report Key8132271
MDR Text Key129297458
Report Number3003442380-2018-00033
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K106648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
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 Lay User/Patient
Device Model NumberMMT-397
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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