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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
Catalog Number 00048011512
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2018
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 sets were not sticking to his skin. The caller alleged that this has occurred with 5 different infusion sets from the same box. The customer alleged the infusion sets from this particular box were defective. No adverse event was reported. The infusion sets were requested to be returned for product 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 Key7635047
MDR Text Key112301662
Report Number3011393376-2018-02660
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,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number00048011512
Device Lot Number1208585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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