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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer called to report that she purchased a box of microlet lancets.When the customer opened the box, she found that 15 of 100 lancets in the box did not have protective covers on them.The device is not expected to be returned for evaluation, as the customer discarded the lancets.A replacement meter kit was sent to the customer.
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 patient's weight was not provided.
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 b09c2s 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 b09c2s.

• 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: 16761435
• Report Number: 1810909-2023-00074
• Device Sequence Number: 11522474
• 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): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2026
• Device Model Number: 6586
• Device Catalogue Number: 81264857, 81264954 (US)
• Device Lot Number: B09C2S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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: 67 YR
• Patient Sex: Female