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

Model Number	6586
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured in report as the patient's initials and weight were not provided.
Event or Problem Description
A customer called to report that one of the lancets from the box of microlet lancets received by the customer did not have a protective cover on it.The customer accidentally pricked her finger with the uncovered lancet.However, no medical attention was required.The customer was advised to return the device for evaluation.Replacement lancets were sent to the customer.
Additional Manufacturer Narrative
Sections d4 and h4 have been updated with the expiration date and manufacture date respectively for microlet lancet lot # c09a7s.
Additional Manufacturer Narrative
The customer did not return the microlet lancets or pictures of lancets associated with the event for evaluation.Only visual assessment of lancets from archival samples and device history record (dhr) review were conducted.Lot number c09a7s associated with the event was packed in shelf box of 100.The archival samples were visually inspected and none of them contain a lancet without protective cap.Additionally, the dhr review indicated that there were no manufacturing errors for the lancets with lot number c09a7s.

• Brand Name: MICROLET
• Common Device Name: 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: 16723890
• Report Number: 1810909-2023-00064
• Device Sequence Number: 17939765
• Product Code: FMK
• UDI-Device Identifier: 00301936586218
• UDI-Public: 00301936586218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6586
• Device Catalogue Number: 81264857, 81264954 (US)
• Device Lot Number: C09A7S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 09/01/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/14/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female