MAUDE Adverse Event Report: PTS DIAGNOSTICS A1CNOW+; A1C CHEMISTRY KIT

Lot Number	2323040
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not yet returned the kit for investigation.Based upon the difference between the a1c results and the lab value, this is being reported out of an abundance of caution.Additional factors contribute to a medical decision being made (i.E.Signs, symptoms, additional gathered data) and a significant difference would result in a retest or additional evaluation/testing.Qc retention testing measured within specification.
Event or Problem Description
The customer reported inconsistent a1c results when comparing the a1c kit values to a recent lab value.There were no allegations of patient/user harm.This event is being reported out of an abundance of caution.

• Brand Name: A1CNOW+
• 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: 20014108
• Report Number: 1836135-2024-00030
• Device Sequence Number: 7257398
• Product Code: PDJ
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)250719(10)2323040
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: Health Professional
• Device Expiration Date: 07/19/2025
• Device Lot Number: 2323040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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