• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNOMEDICAL A/S SILHOUETTE PARADIGM SILHOUETTE PARADIGM INFUSION SET Back to Search Results
Model Number MMT-377
Device Problem Bent (1059)
Patient Problems Diabetic Ketoacidosis (2364); Coma (2417)
Event Date 10/05/2016
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for flow, leak and ventilation to the pcap connector. All test results were within specifications. Batch record 5012911 is verified and found within specifications. Based on the investigation and test results the claimed failure can not be confirmed. Unomedical is actively seeking further information on incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 28-nov-16.
 
Event Description
(b)(4). On (b)(6) 2016 a female diabetic patient on pump therapy tried to bolus and bring blood glucose down. The blood glucose would not come down. On (b)(6) 2016 her boyfriend found her passed out and she was hospitalized, intensive care unit at (b)(6) medical center. Patients blood glucose at time of hospitalization 1000 mg/dl. No further symptoms were reported. She was passed out for 2 days. Cause of hospitalization per hcp: diabetic ketoacidosis (dka). Unknown if patient was wearing pump at the time of hospitalization. Patient was treated with iv drip insulin and fluids. A bent cannula was found on the infusion set. The infusion set has been in use for over 2 days. No further information available.
 
Manufacturer Narrative
On 02-nov-2016: based on the investigation and test results the claimed failure can not be confirmed. If new information becomes available the complaint will be re-opened and appropriate actions will be taken. Clinical evaluation: the patient reported having been into diabetic coma for two days due to a hyperglycemic event. Patient received iv drip insulin and fluids to treat diabetic ketoacidosis. The patient reported self treatment by bolus to bring down blood glucose level with no success. The patient did not report receiving any alarm indicating that there were flow of insulin with no pressure build up. The patient report that in hospital it was found that the site was dislodged and upon removal the cannula was bent. If the cannula becomes dislodged this could cause inadequate administration of insulin to the subcutaneous tissue due to back-tunneling of insulin. Also, in user situations if providing stress of pressure to a partly dislodged cannula this could result in the cannula getting bent if hitting dense tissue. No used infusion set was returned for testing and it is not possible to establish if this event is due to an infusion set malfunction or due to the infusion set accidentally becoming dislodged. No clinical consequences reported due to this event. On 25-oct-2016: the reference samples were visually inspected and tested for flow, leak and ventilation to the pcap connector. All test results were within specifications. Batch record 5012911 is verified and found within specifications. Based on the investigation and test results the claimed failure can not be confirmed. Unomedical is actively seeking further information on incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 28-nov-16.
 
Event Description
(b)(4). On (b)(6) 2016 a female diabetic patient on pump therapy tried to bolus and bring blood glucose down. The blood glucose would not come down. On (b)(6) 2016 her boyfriend found her passed out and she was hospitalized, intensive care unit at (b)(6) center. Patients blood glucose at time of hospitalization 1000 mg/dl. No further symptoms were reported. She was passed out for 2 days. Cause of hospitalization per hcp: diabetic ketoacidosis (dka). Unknown if patient was wearing pump at the time of hospitalization. Patient was treated with iv drip insulin and fluids. A bent cannula was found on the infusion set. The infusion set has been in use for over 2 days. No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSILHOUETTE PARADIGM
Type of DeviceSILHOUETTE PARADIGM 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
548167000
MDR Report Key6053333
MDR Text Key58247691
Report Number8021545-2016-00004
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Model NumberMMT-377
Device Lot Number5012911
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2012
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: 10/25/2016 Patient Sequence Number: 1
-
-