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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM COMFORT

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UNOMEDICAL A/S SILHOUETTE PARADIGM COMFORT Back to Search Results
Model Number MMT-381600
Device Problem No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Coma (2417)
Event Date 04/14/2018
Event Type  Injury  
Manufacturer Narrative
Sincerely apologize the delay reporting of this event. The mdr reportability was identified during a quality check on 29jan2019.
 
Event Description
Unomedical reference number:(b)(4). A male diabetic patient was hospitalized on saturday (b)(6) 2018 at 3:30 am due to hypoglycemia and diabetic coma. Low blood glucose level of 1. 7 mmol/l at time of event. The patient reported that he was in the hospital for few hours and was discharged on the same day. It was stated that the patient did not have a sensor and he fell in to diabetic coma in the night and went to the hospital. The patient reported that before going to sleep he noticed a bump on his skin and he thought that the bump was due to insulin stacking. It was reported that the patient changed the infusion set and site of insertion and gave himself a correction. The patient reported that he went to sleep and checked his blood glucose just before going to bed. It was stated that his wife noticed that he was sweaty and gave him orange juice and sugar. It was reported that the ambulance was called out and he was given glucagon injections to bring his blood glucose back to normal. It was reported that the cause of hospitalization per health care professional was low blood glucose. It was reported that the patient was not wearing the insulin pump at the time of hospitalization and was off the insulin pump less than forty eight hours. No further information available.
 
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Brand NameSILHOUETTE PARADIGM
Type of DeviceCOMFORT
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 Key8288254
MDR Text Key134444367
Report Number8021545-2019-00001
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2020
Device Model NumberMMT-381600
Device Lot Number5214444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2017
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: 01/30/2019 Patient Sequence Number: 1
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