• 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 ® FLEXLINK 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 ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 06593941001
Device Problems Bent (1059); Occlusion Within Device (1423)
Patient Problem Hyperglycemia (1905)
Event Date 12/16/2017
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.
 
Event Description
It was reported that the patient was hospitalized for hyperglycemia while using the infusion set. At 10:00 a. M. , the patient's blood glucose result was 26. 0 mmol/l and he was experiencing symptoms of abdominal pain, vomiting, and had ketones of 2. The patient's infusion set was changed at 11:00 a. M. And upon removing the cannula, the patient's mother reported that the cannula was bent. Also, there was an occlusion within the infusion tubing. After the infusion set was changed, the patient was administered a correction bolus and the blood glucose level remained elevated at 1:00 p. M. The patient's mother called for a taxi and the patient was taken to the hospital. It was later found that the 2nd infusion set had a bent cannula upon removal. The patient's mother believes the bent cannula is due to the patient not being still upon insertion and moving around due to his abdominal pain. The mother reported the patient had multiple occlusion error messages on the infusion device during the early hours of saturday and later throughout the day prior to the patient going to hospital. The mother had pressed the button to confirm acknowledgment of the occlusion without attempting to prime the line or change cannula initially, causing the occlusion to be unresolved and disrupt the insulin delivery, thus causing the elevated blood glucose levels. The blood glucose results at the hospital were not provided. The patient was treated with iv therapy to regulate the blood glucose levels. The patient was released from the hospital on (b)(6) 2017. The infusion set lot number was not provided. The infusion set is not expected to be returned for product evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCU-CHEK ® FLEXLINK INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
UNOMEDICAL DEVICES S.A. DE C.V
avenida fomento industrial lot
parque industrial del norte
reynosa C.P. 8873
MX C.P. 88736
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7175357
MDR Text Key96750304
Report Number3011393376-2018-00086
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
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 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Patient Family Member or Friend
Device Catalogue Number06593941001
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 Received12/19/2017
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: 01/09/2018 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
-
-