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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK SET PARADIGM QUICK-SET PCC

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UNOMEDICAL A/S QUICK SET PARADIGM QUICK-SET PCC Back to Search Results
Model Number MMT-394
Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)
Patient Problems Death (1802); Diabetic Ketoacidosis (2364)
Event Date 07/21/2018
Event Type  Death  
Manufacturer Narrative
On (b)(6) 2019: it is unknown if the mentioned model number and lot number, is the infusion set the patient wore by his death, but it was the last know set distributed to the patient. A follow-up will be submitted no later than 02/01/2019.
 
Event Description
Unomedical reference number (b)(4). Event happened in (b)(6). A (b)(6) male experienced a diabetic ketoacidosis and later died of heart attack. Patient had during 4 hours taken 14 boluses as well as tried to give correction bolus, this was confirmed by his potassium which was 10. Carelink was uploaded and had shown that no delivery alarms was provided to the patient from the pump. Unomedical has not received any information about the infusion set, therefore we have no available case data indicating any causal relation between claimed event and any infusion set malfunction.
 
Manufacturer Narrative
It is unknown if the mentioned model number and lot number, is the infusion set the patient wore by his death, but it was the last know set distributed to the patient. Unomedical has investigated medtronic's pump history, where we can see that the patient changes his infusion set 3 times during the last approx. 24 hours and he is able to prime both the tubing and cannula each time. Pump users are trained in changing their infusion sets as part of the problem solving, to reduce any increased blood glucose levels. However, none of these infusion set changes solves the elevated blood glucose. Based on this information, we do not believe that our infusion set is involved in the event.
 
Event Description
Unomedical reference number (b)(4). Event happened in (b)(6). A (b)(6) male experienced a diabetic ketoacidosis and later died of heart attack. Unomedical has not received any information about the infusion set, therefore we have no available case data indicating any causal relation between claimed event and any infusion set malfunction.
 
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Brand NameQUICK SET PARADIGM
Type of DeviceQUICK-SET PCC
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
aalholmvej 1-3
osted
lejre, 4320
MDR Report Key8211669
MDR Text Key131891210
Report Number3003442380-2019-00001
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2021
Device Model NumberMMT-394
Device Lot Number5217947
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 Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2018
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: 01/03/2019 Patient Sequence Number: 1
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