• 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 UNKNOWN, 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 UNKNOWN, INFUSION SET Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Date 12/12/2017
Event Type  Injury  
Manufacturer Narrative
The claimed failure cannot be confirmed. No lot number nor no reference samples have been received/reported. 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 male patient on pump therapy experienced an hyperglycemic event with blood glucose levels up to 1600 mg/dl that took the patient into a hospitalization. The patient was in a diabetic coma for 4 days. Patient stated that his ex wife came home and tried to wake him up and would not get up, patient was rushed to the hospital and treated to lower blood glucose levels, there was no malfunction or set failure that is confirmed that could have lead the patient into this life threatening event. No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN, INFUSION SET
Type of DeviceUNKNOWN
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
0455816700
MDR Report Key7240388
MDR Text Key98965634
Report Number3003442380-2018-00008
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
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 Received01/04/2018
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: 02/05/2018 Patient Sequence Number: 1
-
-