MAUDE Adverse Event Report: ACCU-CHEK ® FLEXLINK INFUSION SET; SUBCUTANEOUS INFUSION SET

Catalog Number 04631048001

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Manufacturer Narrative

This case, with patient identifier (b)(6) (system 1), is related to case with patient identifier (b)(6) system 2).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 self-adhesive of the infusion set was not sticking well enough resulting in elevated blood glucose levels.

• Brand Name: ACCU-CHEK ® FLEXLINK INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• MDR Report Key: 12581740
• MDR Text Key: 274927700
• Report Number: 3011393376-2021-03111
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 04631048001
• Device Lot Number: 5337705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN.; UNKNOWN INSULIN
• Patient Age: 59 YR