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

Catalog Number 06593941001

Device Problems Bent (1059); Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 12/16/2017

Event Type  Injury  

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

It was reported that the patient was hospitalized for hyperglycemia while using the infusion set.At 10:00 a.M., the patient's blood glucose result was 26.0 mmol/l and he was experiencing symptoms of abdominal pain, vomiting, and had ketones of 2.The patient's infusion set was changed at 11:00 a.M.And upon removing the cannula, the patient's mother reported that the cannula was bent.Also, there was an occlusion within the infusion tubing.After the infusion set was changed, the patient was administered a correction bolus and the blood glucose level remained elevated at 1:00 p.M.The patient's mother called for a taxi and the patient was taken to the hospital.It was later found that the 2nd infusion set had a bent cannula upon removal.The patient's mother believes the bent cannula is due to the patient not being still upon insertion and moving around due to his abdominal pain.The mother reported the patient had multiple occlusion error messages on the infusion device during the early hours of saturday and later throughout the day prior to the patient going to hospital.The mother had pressed the button to confirm acknowledgment of the occlusion without attempting to prime the line or change cannula initially, causing the occlusion to be unresolved and disrupt the insulin delivery, thus causing the elevated blood glucose levels.The blood glucose results at the hospital were not provided.The patient was treated with iv therapy to regulate the blood glucose levels.The patient was released from the hospital on (b)(6) 2017.The infusion set lot number was not provided.The infusion set is not expected to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® FLEXLINK 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: 7175357
• MDR Text Key: 96750304
• Report Number: 3011393376-2018-00086
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/09/2018

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: Patient Family Member or Friend
• Device Catalogue Number: 06593941001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/09/2018
• 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
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR