MAUDE Adverse Event Report: PTS DIAGNOSTICS A1C SELF CHECK; A1C TESTING KIT

Model Number	3070
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleges that their last cartridge pouch already had sample applied to it when they opened the pouch.There were no allegations of patient/user harm.This allegation is being reported out of an abundance of caution.
Additional Manufacturer Narrative
This allegation was reported out of an abundance of caution.It appears the customer cartridge had been previously used post-distribution.

• Brand Name: A1C SELF CHECK
• Common Device Name: A1C TESTING KIT
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer (Section G): PTS DIAGNOSTICS; 510 oakmead pkwy; sunnyvale CA
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN
• MDR Report Key: 17037427
• Report Number: 1836135-2023-00019
• Device Sequence Number: 12376769
• Product Code: PDJ
• UDI-Device Identifier: 00381933070019
• UDI-Public: (01)00381933070019(17)240229(10)2223139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090413
• 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
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: 02/29/2024
• Device Model Number: 3070
• Device Catalogue Number: 3070
• Device Lot Number: 2223139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown