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 Problems Unspecified Infection (1930); Reaction, Injection Site (2442)

Event Date 01/16/2019

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.

Event Description

It was reported that the patient experienced inflammation at the insertion site of the flexlink cannula.This inflammation evolved into a local infection and patient went to the emergency room.At the hospital, the patient was given "inflammatory" and antibiotic treatment prescribed by the doctor.It is unknown how long the patient was hospitalized.The lot number was not provided.The infusion set was requested to be returned for product evaluation.

Event Description

It was reported that the patient experienced inflammation at the insertion site of the flexlink cannula.This inflammation evolved into a local infection and patient went to the emergency room.At the hospital, the patient was given "inflammatory" and antibiotic treatment prescribed by the doctor.It is unknown how long the patient was hospitalized.The lot number was not provided.The infusion set was requested to be returned for product evaluation.Additional information: the patient was contacted via phone on (b)(4) 2019 and she reported that on the third day of use of the cannula, she felt irritation so she removed the cannula from the site (left flank) and found that the site was purple and the skin was hardened and swollen.She went to a public hospital, where she was attended by a general physician, who prescribed the antibiotic foritus for 5 days and advised her to not insert a cannula back in this site.She reported that she has completed the medication.She indicated that there is a little lump at the site and that she is in good health.

• 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: 8285549
• MDR Text Key: 134355458
• Report Number: 3011393376-2019-00400
• 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,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2019
• 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
• Treatment: FORITUS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR