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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 00048011811
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905)
Event Date 08/28/2021
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 no longer available to be returned for evaluation.
 
Event Description
The caller reported that he had to go to hospital due to abscess/hematoma formation from wearing the infusion set. The caller stated that he was treated to stop the bleeding and ice was applied to the area. He was hospitalized for 1-2 hours for this incident. The caller claims that he usually gets pus and infection in the area where the cannula is inserted, but the caller never gave much importance to it. Now the cannula was inserted in the lower back and no problem was found.
 
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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
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key12393446
MDR Text Key268988093
Report Number3011393376-2021-02670
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/06/2021
Device Catalogue Number00048011811
Device Lot Number1280799
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 Received09/03/2021
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 Invalid Data

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
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