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

Lot Number ASKU

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

Patient Problem Reaction, Injection Site (2442)

Event Date 09/21/2018

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.

Event Description

It was reported that the patient experienced an allergic reaction at the site of the infusion sets.It was alleged that the patient had used different sites on the body, including the buttocks, arms, and abdomen and she experienced whitish micro-bubbles at each injection site.The patient's father contacted the doctor and the doctor prescribed unknown dermatological medicines.However, this did not resolve the issue, so the patient discontinued use of the pump/infusion sets.The lot number was not provided.The infusion sets will not be returned for product evaluation.

• 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: 7933858
• MDR Text Key: 122653565
• Report Number: 3011393376-2018-04181
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• 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: 22 YR