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¿II; INSET II 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¿II; INSET II 60/6 GREY Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that the cannula tubing came away from the blue clip that was attached to the site.The patient had high blood glucose level (greater than or equal to 250 mg/dl) and had lower ketone levels.No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSET¿II
Common Device Name
INSET II 60/6 GREY
MDR Report Key8319456
Report Number3003442380-2019-00500
Device Sequence Number1527036
Product Code FPA
UDI-Device Identifier05705244007536
UDI-Public05705244007536
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? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/17/2018
Initial Report FDA Received Date02/08/2019
Patient Sequence Number1
-
-