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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S QUICK-SET PARADIGM INFUSION SET Back to Search Results
Model Number MMT-399
Device Problem No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 07/29/2017
Event Type  Injury  
Manufacturer Narrative
The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description. No used samples returned for investigation nor any lot number provided. No relevant testing could be performed. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). This incident occured in (b)(6). On (b)(6) 2017 a diabetic male patient on pump therapy experienced low blood glucose. He drove to a party (no alcohol, no drugs consumption) and passed out. After he came to himself, he called his brother (rescue assistant) who arrived soon after and called the ambulance. The patient was admitted to hospital ((b)(6)). Blood glucose at time of incident is unknown. Patient was discharged from hospital on (b)(6) 2017. Patient suffered blow-out fracture. The father of the patient reported the incident and assumed that the event was caused by the quick set infusion set. He excluded the possibility that there was moisture between the reservoir and the p-cap. No further information available.
 
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Brand NameQUICK-SET PARADIGM INFUSION SET
Type of DeviceQUICK-SET PARADIGM
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
4548167000
MDR Report Key7107773
MDR Text Key94494433
Report Number3003442380-2017-00026
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
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-399
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2017
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: 12/12/2017 Patient Sequence Number: 1
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