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

Catalog Number 05360188001

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

Patient Problem Unspecified Infection (1930)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Caller reports both her index and ring fingers became infected after using the fastclix lancets.The caller received an unspecified antibiotic for the infection.Requested return of suspect system and replacement was sent.

Manufacturer Narrative

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

• Brand Name: ACCU-CHEK ® FASTCLIX LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; na; pfriemd 9253 6; GM 92536
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4059248
• MDR Text Key: 18028320
• Report Number: 1823260-2014-06783
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/03/2014

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: 05360188001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 060 YR
• Patient Weight: 82