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

Lot Number ASKU

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

It was reported that the self-adhesive of the infusion sets were not sticking well enough.Caller reported this started in 2015, and occurred 6 or 7 times over the next couple years.The customer alleged the infusion sets she had from different boxes/lots were defective.No adverse event was reported.The lot numbers were not provided.The infusion sets were discarded; therefore, no product could be requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® ULTRAFLEX 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: 7282412
• MDR Text Key: 100486410
• Report Number: 3011393376-2018-00812
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2018
• 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: 59 YR