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

Device Problem Unintended Ejection (1234)

Patient Problems Cataract (1766); Eye Injury (1845)

Event Date 10/03/2020

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 customer's mother thought the insertion device was jammed and turned the device upside down to look at it.In doing so, the cannula was accidentally triggered and shot her in the eye.The mother confirmed that no buttons were pressed.The mother went directly to the hospital where she received oral antibiotics and eye drops and was sent home.The next morning she went to the eye clinic and stayed overnight.Due to the injury to the eye, fluid leaked from the eyeball, which had to be glued.The injury also led to a traumatic cataract which had to be operated.

• 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: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 10665245
• MDR Text Key: 210991860
• Report Number: 3011393376-2020-03690
• Device Sequence Number: 1
• Product Code: KZH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention