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

Lot Number ASKU

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 11/23/2017

Event Type  malfunction  

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

Caller alleges requiring hospitalization due to bent cannulas and elevated blood glucose levels.Treatment received was not provided.Requested return of the alleged device for evaluation and replacement was provided.

• Brand Name: ACCU-CHEK ® INSIGHT FLEXLINK PLUS 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): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; na; pfreimd 92536 ; GM 92536
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7067142
• MDR Text Key: 93230205
• Report Number: 3011393376-2017-06345
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 110