MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. MICROLET NEXT; LANCING DEVICE

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

The patient was the initial reporter, so personal information was not entered.No information was captured as the patient's age and weight were not provided.The customer did not provide the product details.Therefore, no information was captured (model # and serial #), and the device manufacture date could not be determined.The lancing device is not 510(k) cleared, therefore, no information was captured.

Event Description

A nurse from (b)(6) reported that while drawing patient's blood to perform the blood glucose test with the microlet next lancing device, the lancet was not released.She attempted to push the lancet from the lancing device and in the process pricked herself.The lancet was contaminated with the patient's blood.The nurse stated that she got a blood work done.The nurse declined to return the device for evaluation.

• Brand Name: MICROLET NEXT
• Type of Device: LANCING DEVICE
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): HTL-STREFA S.A.; registration number: 9613304; adamowek 7; ozorkow lodzkie, 95-03 5; PL 95-035
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142962901
• MDR Report Key: 12009072
• MDR Text Key: 256498934
• Report Number: 1810909-2021-00261
• 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,health professional
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1