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

Lot Number 151409

Device Problem Misfire (2532)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/21/2022

Event Type  malfunction  

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 mother of the customer was handling the accu-chek linkassist and the insertion device ejected the infusion set unintentionally into the mother's thigh region.No medical treatment was required.

• 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: 13444127
• MDR Text Key: 285828390
• Report Number: 3011393376-2022-00386
• 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,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 151409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 03/08/2022; 04/12/2022
• Supplement Dates FDA Received: 03/08/2022; 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Sex: Female