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: ROCHE DIABETES CARE, INC. ACCU-CHEK LINKASSIST; SPRING LOADED INSERTION DEVICE
  • 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
 

ROCHE DIABETES CARE, INC. ACCU-CHEK LINKASSIST; SPRING LOADED INSERTION DEVICE Back to Search Results
Model Number 04530039001
Medical Device Problem Code Unintended Ejection (1234)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/27/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.
 
Event or Problem Description
It was reported that the insertion device ejected the infusion set unintentionally.The cannula fired into the side of the patient's stomach, but no injury was reported.
 
Additional Manufacturer Narrative
Correction to field h5.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCU-CHEK LINKASSIST
Common Device Name
SPRING LOADED INSERTION DEVICE
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10919811
Report Number3011393376-2020-04297
Device Sequence Number16822675
Product Code KZH
UDI-Device Identifier04015630048601
UDI-Public04015630048601
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date (Section B) 06/03/2021
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 Lay User/Patient
Device Model Number04530039001
Device Catalogue Number04530039001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Initial Date Received by Manufacturer 11/30/2020
Supplement Date Received by Manufacturer02/03/2021
05/28/2021
Initial Report FDA Received Date11/30/2020
Supplement Report FDA Received Date02/11/2021
06/03/2021
Patient Sequence Number1
Patient Age28 YR
-
-