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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S QUICK-SET PARADIGM INSULIN INFUSION SET Back to Search Results
Model Number MMT-394
Device Problem Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Coma (2417)
Event Date 09/13/2017
Event Type  Injury  
Manufacturer Narrative
Patient cannot provide the lot number (and no set was returned from patient), but insist it was included in the recent medtronic recall (b)(4). Should new relevant information become available, unomedical will re-open the case and will submit a follow-up mdr to fda.
 
Event Description
(b)(4). A female diabetic patient is receiving insulin treatment by a medtronic insulin pump with a glucose sensor and a medtronic infusion set, type quick-set paradigm, model mmt-394. She reports that on (b)(6) 2017 she experienced an unusual drop in blood sugar causing her into 'diabetic shock' while at an airport where she passed out in a restaurant chair. Bystanders called emergency staff and emt revived her and brought her to a medical center where she stayed for four hours until blood glucose normalised. She feels that the incident is related to the reason for the recent medtronic recall ((b)(4)). Lot number is not provided and no set is returned, but patient states the lot was one of the recalled lots.
 
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Brand NameQUICK-SET PARADIGM
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 Key7005507
MDR Text Key91185249
Report Number3003442380-2017-00018
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
Remedial Action Recall
Type of Report Initial
Report Date 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-394
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 Received10/27/2017
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: 11/07/2017 Patient Sequence Number: 1
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