MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® FASTCLIX LANCETS

Catalog Number ASKU

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/13/2014

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).The year is the only known part of manufacture date.We have defaulted to the first of the year.Drums were returned with missing lancets, but without the needles that fell out, the manufacturer was unable to determine the cause.

Event Description

Caller reports lancets were not retained within the drum of the fastclix device.It was reported that several lancets had fallen out of the device.The patient's mother was stuck by two needles on the sofa.No inflammation was observed, it was not known whether or not the needles had prior use.No adverse event reported.Requested return of suspect device and replacement was sent.

Manufacturer Narrative

The event occurred in (b)(6).The year is the only known part of manufacture date.We have defaulted to the first of the year.

• Brand Name: ACCU-CHEK ® FASTCLIX LANCETS
• Type of Device: LANCETS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): WEIDMANN MEDICAL TECHNOLOGY; industriestrasse 96; na; bad ragaz 7310 ; SZ 7310
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4169578
• MDR Text Key: 12671661
• Report Number: 1823260-2014-07838
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: WPB084
• Other Device ID Number: 00700006740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1