Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY
  • 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
 

INSET¿; INSET I 60/6 GREY Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set cannula was kinked.Reportedly, the patient's blood glucose was high and experienced symptoms of diabetic ketoacidosis, which were self-treated with a correction bolus by the pump.Upon arrival in the emergency room, the patient's blood glucose levels were 450 mg/dl, where the stay was for few hours and was given insulin drip and some unspecified fluids.The patient left the emergency room, when blood glucose level was around 400 mg/dl and was still unstable.Subsequently, the patient was admitted in the intensive care unit and was given insulin drip as corrective treatment which resolved the issue.The infusion set was used for one day.The patient was hospitalized for two days and there was no permanent damage to the patient.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSET¿
Common Device Name
INSET I 60/6 GREY
MDR Report Key8542881
Report Number3003442380-2019-01304
Device Sequence Number2443175
Product Code FPA
UDI-Device Identifier05705244006874
UDI-Public05705244006874
Combination Product (Y/N)N
PMA/510(K) Number
K032854
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2017
Initial Report FDA Received Date04/24/2019
Patient Sequence Number1
-
-