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

Lot Number ASKU

Device Problems Kinked (1339); Leak/Splash (1354)

Patient Problem Hyperglycemia (1905)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer reported she was hospitalized with, diabetic ketoacidosis, as a result of the cannula kinking.She could not remember for this incident if the cannula was leaking as well or just kinked.At an unknown time the patient received a blood glucose result of "hi mg/dl" (which on the system indicates a result in excess of 600 mg/dl) on her aviva combo system.The patient attempted to self-treat by giving herself insulin injections, but her blood glucose was not coming down.The patient began to experience elevated blood glucose symptoms of vomiting, dehydration, and confusion.A family member transported the patient to the hospital.The blood glucose results obtained on the hospital's meter were not provided.The patient was treated with an insulin iv and was hospitalized for 3 days.The customer is attributing her high blood to either the cannula kinking or leaking.Customer reported her sites were always kinking and sometimes would cause her sites to leak.Customer states she had multiple sets of infusion that were kinking.She does not have the lot information for any of her infusion sets.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: 6677165
• MDR Text Key: 78700701
• Report Number: 3011393376-2017-03819
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 06/19/2017
• 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
• Treatment: HUMALOG U100 INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 64