MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® MULTICLIX; LANCET DEVICE

Catalog Number ASKU

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2014

Event Type  malfunction  

Event Description

Reporter stated lancet protrudes and fell completely out through the properly positioned end cap of the multiclix device.No accidental stick reported.No adverse event reported.Customer did not provide the lot number of the device, nor the lancets.The manufacturer requested return of suspect product for evaluation.

Manufacturer Narrative

The event occurred in (b)(6).

• Brand Name: ACCU-CHEK ® MULTICLIX
• Type of Device: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ASKU; asku; na; asku ASKU
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4303794
• MDR Text Key: 5055394
• Report Number: 1823260-2014-09628
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• 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: ASKU
• Other Device ID Number: 00700006749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Manufacturer Received: 11/10/2014
• 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 Age: 020 YR