• 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 ® RAPID-D INFUSION SET SUBCUTANEOUS 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
 

ROCHE DIABETES CARE, INC. ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 04541014001
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Hyperglycemia (1905)
Event Date 06/13/2018
Event Type  malfunction  
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 Description
The caller reported the adhesive from the infusion set was not sticking to her skin, which caused the cannula to slip out of the body. The customer experienced elevated blood glucose levels. No adverse event was reported. The lot number was not provided. The infusion set was discarded; therefore, no product could be requested to be returned for product evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCU-CHEK ® RAPID-D INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
CLINICO MEDICAL SP Z O.O.
ul. kocha 1
na
blonie 55-33 0
PL 55-330
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7629457
MDR Text Key112044129
Report Number3011393376-2018-02615
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04541014001
Device Lot NumberASKU
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 Received06/14/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 06/22/2018 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN PEN
-
-