MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SOFTCLIX ® LANCETS

Catalog Number ASKU

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

Patient Problem Unspecified Infection (1930)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Caller reports developing a blister on her finger after using the sofclix device.She has been applying an antibiotic cream to her finger and was advised by her doctor to avoid using the finger for at least 10 days.Requested return of suspect device.

Manufacturer Narrative

The event occurred in (b)(6).

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: SOFTCLIX ® LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; na; bad oeynhausen 3254 9; GM 32549
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3881722
• MDR Text Key: 4542161
• Report Number: 1823260-2014-04446
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: GT
• 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: 08/04/2014

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: Patient Family Member or Friend
• Device Catalogue Number: ASKU
• Device Lot Number: BAZ087
• Other Device ID Number: 00700006731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 058 YR