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

Lot Number ASKU

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Vomiting (2144)

Event Date 01/11/2021

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.Product no longer available for return.

Event Description

It was reported that the infusion set on the headset was leaking.The patient reported that on the day of the event she went to school to take an exam.When she arrived at school, she noticed that the adhesive of the plaster was wet.In addition, the cannula was kinked, resulting in under-delivery of insulin and high blood glucose levels.The patient's skin was hurt by the folded cannula.She had a blood glucose level of hi mg/dl (> 600 mg/dl) and was treated by the school doctor who gave her 10 units of insulin (humalog regular insulin).After a few hours, the blood glucose level decreased to 400 mg/dl.During the exam, her blood glucose, oxygen level and blood pressure were checked regularly by the school nurse.The patient had symptoms of vomiting, polydipsia and polyuria.After finishing the exam, she went back home, changed the cannula and her blood glucose level stabilized.

• 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: 11313134
• MDR Text Key: 231317598
• Report Number: 3011393376-2021-00477
• 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: Other
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Device Age: NULL
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR