• 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 INSIGHT FLEX 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 INSIGHT FLEX SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 04/05/2020
Event Type  Injury  
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. Product is not expected to be returned.
 
Event Description
It was reported that the patient was hospitalized for diabetic ketoacidosis using the infusion set. On (b)(6) 2020 the patient's blood glucose level rose to over 300 mg/dl, he suffered from nausea and persistent vomiting. The user changed the infusion set and injection site several times, but without success. On (b)(6) 2020 he was admitted to hospital because of bilious vomiting and deterioration of his general condition. The patient was treated with infusion therapy for rehydration and intravenous insulin therapy. On (b)(6) 2020 the user was switched back to pump therapy. It was reported that the pump catheter was bent and therefore showed a metabolic imbalance. The patient repeatedly had high blood glucose levels in hospital, so the basal rate was changed. The patient had used a catheter that he had brought from home and which had expired. This catheter was replaced by a new one because the blood glucose levels were again too high. The rest of the hospital stay went without complications. The patient was hospitalized until (b)(6) 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCU-CHEK INSIGHT FLEX
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
GERRESHEIMER REGENSBURG GMBH
hirtenstrasse 50
na
pfreimd 92536
GM 92536
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key10239223
MDR Text Key197775607
Report Number3011393376-2020-02372
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
Type of Report Initial
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeNULL
Event Location No Information
Date Manufacturer Received06/29/2020
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: 07/07/2020 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
-
-