MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SAFE-T-PRO; LANCET

Model Number SAFE-T-PRO

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.

Event Description

The initial reporter stated they received a box of safe-t-pro lancets, but all labeling provided with the box did not contain a lot expiration date.

Manufacturer Narrative

No product was returned for investigation.All product batches of the roche diabetes care gmbh are controlled with regard to the quality requirements of the product prior to delivery.If all quality requirements are fulfilled in the quality control process, goods are released and ready for delivery.All non-conforming products are handled in accordance to iso 13485.

• Brand Name: SAFE-T-PRO
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11174011
• MDR Text Key: 231797156
• Report Number: 1823260-2021-00180
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAFE-T-PRO
• Device Catalogue Number: 03136752001
• Device Lot Number: 432016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1