MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK SOFTCLIX LANCETS

Catalog Number 03144844001

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Event Description

The customer complained that his accu-chek softclix lancets don't fit properly into his accu-chek softclix lancet device.The customer stated the lancets were white and looked like the accu-chek softclix lancets except they were too small and did not fit snugly into the device.The lancet does not touch the sides of the lancet holder.When the customer puts the end cap on the device the needle protrudes outside of the cap.The customer has discarded all of the packaging and no specific product information is available.No adverse event occurred.The lancet device and lancets were requested for investigation.

Manufacturer Narrative

The customer returned 24 unused softclix lancets.The lot number is not known.The customer did not return the lancet device.The customer's allegation could not be confirmed.All 24 received lancets were tested with a test lancing device (accu-chek softclix, lot bba068) at 11 different depth settings.For each attempt, the needle correctly produced a puncture hole, retracted and ejected properly.Each lancet could be inserted into the lancing device without any problems.The lancets were investigated with a stereo microscope, but no abnormalities could be observed in terms of the customer's allegation.No malfunction was identified.The customer did not return the lancing device therefore no further investigation could be performed.

• Brand Name: ACCU-CHEK SOFTCLIX LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6059905
• MDR Text Key: 58526988
• Report Number: 1823260-2016-01641
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03144844001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1