MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. MICROLET2; BLOOD GLUCOSE FINGER STICKING DEVICE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 07/13/2016

Event Type  Injury  

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.

Event Description

A nurse in the (b)(6) accidentally injured herself while removing a used lancet from the microlet2 device.She removed the lancet manually without first putting the safety cap on the lancet.She is expected to follow her facility's incident protocol.The caller was advised to return the device for investigation.

• Brand Name: MICROLET2
• Type of Device: BLOOD GLUCOSE FINGER STICKING DEVICE
• 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: roger sonnenburg ; 430 s. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 5841233
• MDR Text Key: 50969234
• Report Number: 1826988-2016-00304
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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