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

Lot Number 5175218

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

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

The customer reported the adhesive from the infusion sets were not sticking to her skin.The caller reported this occurred with two cannulas from the same box.The customer alleged the infusion sets she had from a particular box were defective.No adverse event was reported.

• Brand Name: ACCU-CHEK ® TENDERLINK 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 A/S; aaholmvej 1 - 3; na; osted 4320 ; DA 4320
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7510180
• MDR Text Key: 108134234
• Report Number: 3011393376-2018-02029
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Lot Number: 5175218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR