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

Lot Number ASKU

Device Problem Obstruction of Flow (2423)

Patient Problem Hyperglycemia (1905)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the (b)(6).While this product is not sold in the united states, it is like or similar to a product marketed in the united states.H3 other text : product no longer available for return.

Event Description

The patient's mother reported that the infusion device displayed occlusion error messages leading to her daughter experiencing hyperglycemia on (b)(6) 2023.At the hospital the patient was treated with subcutaneous insulin administration and her pump was put in stop mode.The mother informed that when changing the infusion set and insulin, the occlusion alarms stopped.The duration of hospitalization is not known.

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18474109
• MDR Text Key: 332421128
• Report Number: 3011393376-2024-00089
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

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: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/09/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female