MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® LINKASSIST; SPRING LOADED INSERTION DEVICE

Lot Number 128

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 07/29/2022

Event Type  Injury  

Event Description

The caller alleged that the insertion device was not fully inserting the cannula properly.It was alleged that the linkassist device would not fully insert the cannula into the skin; which resulted in elevated blood glucose levels.On (b)(6) 2022 the customer went to the hospital and was diagnosed with diabetic ketoacidosis.The customer was treated with buscopan and dipyrone and was placed on an iv.The customer was hospitalized for one day.

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.

• Brand Name: ACCU-CHEK ® LINKASSIST
• Type of Device: SPRING LOADED INSERTION DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): TEUSCHER KUNSTSTOFF-TECHNIK AG; niklaus-wengi-strasse 38; na; grenchen 2540 ; SZ 2540
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 15274483
• MDR Text Key: 298380596
• Report Number: 3011393376-2022-02494
• Device Sequence Number: 1
• Product Code: KZH
• 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,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male