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

Lot Number ASKU

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

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 insertion device ejected the infusion set unintentionally.No adverse event reported.The lot number was not provided.The insertion device cannot be returned for legal and customs issues.

• 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: 6792242
• MDR Text Key: 82672105
• Report Number: 3011393376-2017-04584
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR