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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC QUICK-SET PARADIGM; INSULIN PUMP INFUSION SET
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UNOMEDICAL A/S MEDTRONIC QUICK-SET PARADIGM; INSULIN PUMP INFUSION SET Back to Search Results
Model Number MMT-386
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 12/07/2017
Event Type  Death  
Manufacturer Narrative
Unomedical is actively seeking further information.Presently we do not know cause of death, date of death or whether the infusion sets may possibly be causally involved or not.We do hope to provide a follow-up mdr within the a months' time.
 
Event Description
(b)(4).A mother of a diabetic son reports that her son has passed away.Mother has the son's remaining equipment and has heard that some items were recalled.She think that her son's death was due to the pump which had recently been replaced.Mother informs of six lots with 57 of remaining (unused) infusion sets: lot 1-5143650(10), lot 2-5143647(7) , lot 3-5164672(10), lot 4-5170768(10) , lot 5-5143653(10) , lot 6-5174463(10).All six above lots are mmt-386 models of quick-set paradigm and are all affected by the medtronic global recall fa784 issued 11-sep-2017.At present we have no further information.We are trying to get more information.
 
Manufacturer Narrative
Unomedical is actively seeking further information.Presently we do not know cause of death, date of death or whether the infusion sets may possibly be causally involved or not.We do hope to provide a follow-up mdr within the a months' time.New - 15-may-2018: new info is date of death is (b)(6) and that the patient was an adult.Return of the used device has been requested but has not arrived at our testing facility.If we receive the set we will investigate it and supply fda with a further follow-up emdr.Helpdesk staff informs that the notes suggested that the coroner did not do an autopsy and there was no actual proof of hypoglycemia, but he believed that hypoglycemia might have been involved.Thus, it remains unknown if the patient experienced any malfunction with the infusion set.Likewise, it is uncertain whether an episode of hypoglycemia actually occurred prior to death.
 
Event Description
Unomedical reference: (b)(4).A mother of a diabetic son reports that her adult son has passed away at home on (b)(6) 2017.Mother has the son's remaining equipment and has heard that some items were recalled.She think that her son's death was due to the pump which had recently been replaced.Mother informs of six lots with 57 of remaining (unused) infusion sets: lot 1-5143650(10), lot 2-5143647(7), lot 3-5164672(10), lot 4-5170768(10), lot 5-5143653(10), lot 6-5174463(10).All six above lots are mmt-386 models of quick-set paradigm and are all affected by the medtronic global recall fa784 issued (b)(6) 2017.
 
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Brand Name
MEDTRONIC QUICK-SET PARADIGM
Type of Device
INSULIN 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 Key7424561
MDR Text Key105241719
Report Number3003442380-2018-00017
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244006577
UDI-Public05705244006577
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 Other
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-386
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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