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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S SILHOUETTE PARADIGM INFUSION SET Back to Search Results
Model Number MMT-381
Device Problem No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Coma (2417)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for flow, leak and ventilation to the pcc reservoir connector. All test results were within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and the reference samples from the same lot number. According to unomedical's traceability records, no relevant deviations were found. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). Fda report number: mw5072202. On (b)(6) 2017 a diabetic patient on pump therapy fell into diabetic coma and required the emergency services of the paramedics when the patients partner heard the patient breathing strangely and was not able to arouse the patient. The paramedics checked the blood glucose and it was so low they were not able to get a reading. The paramedics were able to treat the patient and eventually revive the patient after an hour. The patient recently found out of medtronics recall of the mmt-381 infusion set lot number 5150522 which the patient had been using at the time of the incident. It leads the patient to believe that the hypoglycemic coma incident was due to the failure of the infusion set since there was no other explanation as to why the patient's blood glucose would have been dropped so low. The incident was very unsettling and caused the patient a great deal of emotional distress and more. No further information available.
 
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Brand NameSILHOUETTE PARADIGM INFUSION SET
Type of DeviceSILHOUETTE 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
4558167000
MDR Report Key7124939
MDR Text Key95182318
Report Number8021545-2017-00008
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244008588
UDI-Public05705244008588
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 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberMMT-381
Device Lot Number5150522
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2016
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: 12/18/2017 Patient Sequence Number: 1
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