MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® FASTCLIX; LANCET DEVICE

Catalog Number 00700006744

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/18/2017

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

The caller reported that a caregiver accidentally pricked herself with a patient's fastclix device and would be seeking medical treatment.The caller alleged the caregiver would receive a vaccination for the accidental stick.The lot number was not provided.The suspect device is no longer available to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® FASTCLIX
• Type of Device: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; na; pfreimd 92536 ; GM 92536
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7009947
• MDR Text Key: 91347052
• Report Number: 3011393376-2017-05985
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 00700006744
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention