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

Lot Number 5329885

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

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Injection Site Reaction (4562)

Event Date 10/08/2021

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.

Event Description

It was reported that the patient experienced an infection at the insertion site while wearing the infusion set.The caller reported that on (b)(6) 2021 she inserted the accu-chek flexlink infusion set into her thigh.A few hours later she felt pain at the insertion site and noticed some swelling and her blood glucose levels were elevated.She kept the cannula inserted until (b)(6) 2021, and then decided to remove it as she was experiencing a lot of pain.Once she removed the cannula she had a purple hematoma, swelling, and pain.On (b)(6) 2021 she bumped the site and pus discharged and swelling increased.The customer took medication she had at home of dexamethasone acetate 1 mg/g and neomycin sulphate bacitracin zincid 5 mg/g + 250 iu/g, but she reported that it wasn¿t getting any better.On (b)(6) 2021 the customer went to the hospital.She stayed under observation at the hospital for 6 hours and was given analgesics and an unknown injection.The doctor at the hospital also prescribed her clavulin 500+125mg from 08 to 08 hours.She started the use of this ointment on (b)(6) 2021.The customer reported that the affected site is still red, but swelling has now reduced.

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12699366
• MDR Text Key: 278537450
• Report Number: 3011393376-2021-03343
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Lot Number: 5329885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN CARDIOVASCULAR MEDICATION; UNKNOWN NEUROPATHY MEDICATION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female