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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/20/2024

Event Type  Injury  

Event Description

A customer reported that he received a new meter kit from amazon and a microlet lancet was already placed on the lancing device that came with the meter kit.The customer sustained an accidental needlestick injury from this microlet lancet.The customer stated that he went to his doctor.As the customer was experiencing anxiety due to the fingerstick injury, he was prescribed a mediation to treat the anxiety.Additionally, the customer stated he was ordered to take tetanus and rabies exams along with other unspecified exams.Upon follow-up, the customer confirmed that the exam results were negative.

Manufacturer Narrative

The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.The customer did not provide the product information.Therefore, no information was captured in section d4 (model #, lot # and expiration date), and the device manufacture date (h4) could not be determined.

• Brand Name: MICROLET
• Type of Device: BLOOD GLUCOSE LANCETS
• 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 ; 9142361830
• MDR Report Key: 18911140
• MDR Text Key: 337731835
• Report Number: 1810909-2024-00044
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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
• Date Manufacturer Received: 02/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male