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

Catalog Number 04631293001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction, Injection Site (2442)

Event Date 05/01/2019

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.No product will be returned as the customer disposed of it.

Event Description

It was reported that the patient has been having skin irritation from the infusion set cannula.In (b)(6) 2019 the patient inserted the cannula and had instant pain and removed the cannula.There was a gush of blood where she had hit a blood vessel.She had to see a doctor for treatment because the wound went septic.The nurse had to use a poultice to draw out the infection.This has now left a scar on the right hand side of her hip.The user changed her insertion site multiple times, but each site is causing pain and irritation each time the product is used.

• Brand Name: ACCU-CHEK ® FLEXLINK 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): 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 Key: 9595730
• MDR Text Key: 175199683
• Report Number: 3011393376-2020-00164
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04631293001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Device Age: NULL
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR