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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-378
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 08/13/2017
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for ventilation to pcc. 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
Unomedical reference number: (b)(4). On (b)(6) 2017 a diabetic patient on pump therapy experienced low blood glucose and was unconscious. Ems dispatched and then patient was admitted to hospital ((b)(6) medical center). Cause of hospitalization per hcp: patient passed out and low blood glucose level. The patient was wearing the pump at time of hospitalization. Blood glucose at time of incident is unknown. The patient was unconscious for 2 weeks. The patient was in icu for 3 weeks and was in hospital stay for 6 weeks. Patient left hospital on oxygen. 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
548167000
MDR Report Key7107646
MDR Text Key94482487
Report Number8021545-2017-00007
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 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 Expiration Date12/01/2021
Device Model NumberMMT-378
Device Lot Number5175266
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
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: 12/12/2017 Patient Sequence Number: 1
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