MAUDE Adverse Event Report: BAYER BAYER MICROLET 2

Catalog Number 6606

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Client states that she has been using the device for some time now and the springs became worn out from repeated use.She contacted bayer.The representative asked her the color of the lancet holder.She stated that she asked why they needed to know but the agent did not answer.She said, she later contacted the insulin pump manufacturer, and the agent also stated he did not know why the color was requested.She then called bayer again and was told that they were replacing the lancet holders that were blue and grey with white holders because the white was an upgrade.Client stated that two replacements have been sent and both are still blue.So she called bayer and they stated that they did not know which colors they grabbed off the shelf and dispatched.Client says she is still in possession of the two blue holders.Client says she is upset because they are still dispatching the wrong blue and grey, not looking at the lot numbers, expiration dates or the sterilization dates.She stated that bayer should have discarded all of the blue and grey holders to avoid resending them as replacements.She states that, "bayer does not care and should be more aware that we depend on them to manage the disease.".

• Brand Name: BAYER MICROLET 2
• Type of Device: BAYER MICROLET 2
• Manufacturer (Section D): BAYER
• MDR Report Key: 4466265
• MDR Text Key: 5397635
• Report Number: MW5040453
• Device Sequence Number: 1
• Product Code: FMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: 6606
• Device Lot Number: S28F1S
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 74