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

Lot Number ASKU

Device Problem Obstruction of Flow (2423)

Patient Problem Hyperglycemia (1905)

Event Date 08/17/2022

Event Type  Injury  

Event Description

The caller reported that the patient experienced an occlusion within the infusion set, which led to elevated blood glucose levels.The customer went to see her doctor due to hyperglycemia and the doctor treated the customer with an insulin injection.It was reported that the headset was not changed properly and the same insertion site was always used.No further treatment was required.

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.Material is no longer available to be returned.

• Brand Name: ACCU-CHEK ® SPIRIT TENDERLINK 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 A/S; aaholmvej 1 - 3; na; osted 4320 ; DA 4320
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 15286707
• MDR Text Key: 298559559
• Report Number: 3011393376-2022-02518
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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
• Date Manufacturer Received: 08/17/2022
• 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: 78 YR
• Patient Sex: Female