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

Lot Number 5318887

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

Patient Problems Hyperglycemia (1905); Skin Inflammation/ Irritation (4545)

Event Date 05/22/2021

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 suffered from hyperglycemia and skin inflammation, as a result of an infection by bacteria arising from the cannula of the head set.This was diagnosed in hospital by the hospital staff.The patient was hospitalized and treated with intravenous antibiotic administration.

• 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: 11953242
• MDR Text Key: 254837527
• Report Number: 3011393376-2021-01739
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2022
• Device Lot Number: 5318887
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 12