MAUDE Adverse Event Report: BAYER HEALTHCARE LLC MICROLET2; BLOOD GLUCOSE LANCING DEVICE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/29/2015

Event Type  Injury  

Event Description

A (b)(6) customer reported an accidental finger stick with the microlet2.No further information was provided.

Manufacturer Narrative

Lancing devices are not serialized or assigned lot numbers, so it is not possible to determine a manufacture date.Lancing devices are also not 510(k) cleared.In some countries outside the us, customer information is not provided due to privacy laws.

• Brand Name: MICROLET2
• Type of Device: BLOOD GLUCOSE LANCING DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: roger sonnenburg ; 430 s. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 4524848
• MDR Text Key: 5405743
• Report Number: 1826988-2015-00061
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1