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

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

The returned device was not evaluated as the event of accidental needlestick injury was not associated with the malfunction of the device.As per the microlet 2 lancing device user guide, under potential biohazard section " always dispose of the used lancet properly to prevent injury or contamination to others." the ascensia diabetes care employee will be trained on handling of biohazardous materials.The patient was the initial reporter, so personal information was not entered.No information was captured as the patient's weight was not provided.The product information was not provided.The manufacture date could not be determined and lancets are not 510(k) cleared.

Event Description

An ascensia diabetes care employee from (b)(6) received a microlet 2 lancing device from the customer for evaluation of a separate event.She was wearing gloves while unpacking the returned items, however, she accidentally pricked the palm of her right hand with the microlet lancet that came in installed with the returned lancing device.The employee's blood was drawn and she went to the hospital for full blood work-up, which produced normal results, with no infection.A follow-up blood work-up is scheduled in three months.

Manufacturer Narrative

Section e1 of the initial report indicated the country of origin as usa.The correct country of origin for this event is australia.

• Brand Name: MICROLET
• Type of Device: BLOOD GLUCOSE LANCETS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 10777688
• MDR Text Key: 214424837
• Report Number: 1810909-2020-00578
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR