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

Lot Number	C09D3S
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional 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 model # (d4) was not provided.
Event or Problem Description
A customer called to report that two of the lancets from the box of the microlet lancets received by the customer did not have a protective cover on it.The customer accidentally pricked his finger with the uncovered lancet.However, no medical attention was required.A replacement meter kit was sent to the customer.
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 c09d3s 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 c09d3s.

• 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: 17548370
• Report Number: 1810909-2023-00190
• Device Sequence Number: 20548746
• 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
• Report Date (Section B): 07/24/2023

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 Lot Number: C09D3S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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: 71 YR
• Patient Sex: Male