MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC MICROLET; BLOOD GLUCOSE LANCETS

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient information na.The product information was not provided.The manufacture date could not be determined and lancets are not 510(k) cleared.

Event Description

It was reported from a (b)(6) sales manager, she saw a newspaper article referencing a health fair where blood glucose testing was performed.The article pointed out that lancets were not consistently changed between attendees.Contour next one kits and accessories were being used at the health fair, so it is assumed the microlet lancets were also used.The article stated toronto public health officials were urging up to 30 people to see a doctor for follow up as a precautionary measure.Event organizers did not record who took the test, and the number of people potentially affected is an estimate based on public health's investigation.Officials spoke to event organizers and staff about proper procedures to test for diabetes.There was no issue with product performance so product was not expected to be returned for evaluation.Product was not replaced.

• Brand Name: MICROLET
• Type of Device: BLOOD GLUCOSE LANCETS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s beiger st; mishawaka, IN 46544 ; 5743149617
• MDR Report Key: 7446879
• MDR Text Key: 106043680
• Report Number: 1826988-2018-00066
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• 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