MAUDE Adverse Event Report: PTS DIAGNOSTICS A1C SELFCHECK; A1C CHEMISTRY KIT

Lot Number	2310037
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer result per the cdc table, would place the patient in "normal" category, while their lab result is in the "diabetic" category.While the decision trees and medical opinion ("under-recovery would produce a value that would indicate improvement in control, but would not be the basis of any change in therapy.") determine that an mdr is not required, one will be submitted out of an abundance of caution.The risk to the patient is low, and no clinical action was taken based upon the result received by their a1c kit.The customer did not respond to follow-up attempts to troubleshoot on a replacement kit.Qc retention of the lot reported was tested and measured within specification.
Event or Problem Description
The customer reported receiving an a1c value of 5.0% in comparison to their lab value of 9.0% a couple days later.There were no allegations of patient/user harm.This event is being reported out of an abundance of caution.

• Brand Name: A1C SELFCHECK
• Common Device Name: A1C CHEMISTRY KIT
• Manufacturer (Section D): PTS DIAGNOSTICS; 510 oakmead pkwy; sunnyvale CA 94085
• Manufacturer (Section G): PTS DIAGNOSTICS; 510 oakmead pkwy; sunnyvale CA 94085
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN ; 3178705610
• MDR Report Key: 18504570
• Report Number: 1836135-2024-00003
• Device Sequence Number: 7948781
• Product Code: PDJ
• UDI-Device Identifier: 00311917169835
• UDI-Public: (01)00311917169835(17)241125(10)2310037
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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: 11/25/2024
• Device Lot Number: 2310037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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