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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK PLUS INFUSION SET; SUBCUTANEOUS INFUSION SET
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK PLUS INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Skin Irritation (2076)
Event Date 04/18/2019
Event Type  Injury  
Manufacturer Narrative
No product will be returned for evaluation.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 is reported that customer experienced general skin problems of redness and abscesses on the puncture areas and required surgery.
 
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Brand Name
ACCU-CHEK ® FLEXLINK PLUS INFUSION SET
Type of Device
SUBCUTANEOUS 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 Key8736639
MDR Text Key149257943
Report Number3011393376-2019-02310
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 Other
Type of Report Initial
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot NumberASKU
Was Device Available for Evaluation? No
Device Age NULL
Date Manufacturer Received06/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
NOVORAPID INSULIN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age51 YR
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