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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Bent (1059)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 10/09/2017
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized for diabetic ketoacidosis while using the infusion set. The cannula of the infusion set was bent which caused elevated blood glucose levels. At the hospital, the patient was scanned and the doctors found the cannula was bending inside the stomach which caused the insulin to not to be delivered around the body properly. The blood glucose results and the type of treatment given to the patient at the hospital were not provided. The patient was admitted into the hospital twice within 24 hours. It is unknown how long the patient was in the hospital. It was reported that the patient now suffers with her kidneys and the lower part of her stomach. The infusion set lot number was not provided. Return of the suspect device was requested for evaluation. Additional information: the patient was admitted into the hospital on a monday morning and the blood glucose levels were "hi" and she had ketones of 4. 7. The patient was released from the hospital on tuesday evening. The patient was readmitted on wednesday morning and she was released on friday evening. The blood glucose level was "hi" and she had ketones of 5+ when she was admitted the second time. The patient received treatment, but the type of treatment was unknown.
 
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 diabetic ketoacidosis while using the infusion set. The cannula of the infusion set was bent which caused elevated blood glucose levels. At the hospital, the patient was scanned and the doctors found the cannula was bending inside the stomach which caused the insulin to not to be delivered around the body properly. The blood glucose results and the type of treatment given to the patient at the hospital were not provided. The patient was admitted into the hospital twice within 24 hours. It is unknown how long the patient was in the hospital. It was reported that the patient now suffers with her kidneys and the lower part of her stomach. The infusion set lot number was not provided. Return of the suspect device was requested for evaluation.
 
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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 Key7041998
MDR Text Key104369909
Report Number3011393376-2017-06092
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,Followup,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
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: 11/17/2017 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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