MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. SOFTCLIX ® LANCETS

Catalog Number 11623656001

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

Patient Problem Unspecified Infection (1930)

Event Date 12/06/2014

Event Type  Injury  

Event Description

The customer used the lancing device and discharged the used lancet onto the floor and then accidently stepped on it.It did not break off inside her foot.She pulled needle out herself.Her foot swelled up and she went to the podiatrist the next day.She stated it was infected and she took amoxicillin for five days for the infection.Return of suspect device was requested and replacement was sent.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.The year is the only known part of manufacture date.We have defaulted to the first of the year.(b)(4).

• Brand Name: SOFTCLIX ® LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): FACET TECHNOLOGIES LLC; 3900 north commerce drive; na; atlanta GA
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250 ; 3175212484
• MDR Report Key: 4895994
• MDR Text Key: 15246275
• Report Number: 3011393376-2015-01638
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2015

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: Lay User/Patient
• Device Catalogue Number: 11623656001
• Device Lot Number: BBA164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 056 YR
• Patient Weight: 91