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

Lot Number 5355940

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

It was reported that the self-adhesive of the infusion set was wet with insulin resulting in elevated blood glucose levels.The reporter noticed the cannula was a little bent when removing the infusion set.

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.

• 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: 15870504
• MDR Text Key: 304437519
• Report Number: 3011393376-2022-03500
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Lot Number: 5355940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Age: 10 YR
• Patient Sex: Female