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

Lot Number	9405803
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is being reported out of an abundance of caution.Inspection of lot records for both lots indicate that at no point during any production activities did either lot overlap (manufactured months between).Only one returned cartridge had the printed code ba (mismatch), however this pouch had already been opened by the customer.All returned unopened pouches and all inspected unopened retention pouches had correct lot information and the correct printed code.The customer kit had left pts diagnostics control.
Event or Problem Description
The customer reported that the printed code on their cartridge (ba) did not match the printed code on the analyzer (bh).There were no allegations of patient/user harm.There were no allegations of incorrect results (the customer did not proceed with testing).

• Brand Name: A1CNOW+ TEST KIT
• Common Device Name: A1C TEST SYSTEM
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN ; 3178705610
• MDR Report Key: 20918997
• Report Number: 1836135-2024-00045
• Device Sequence Number: 5108052
• Product Code: PDJ
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)251204(10)9405803
• 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): 12/12/2024

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: 12/04/2025
• Device Lot Number: 9405803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/12/2024
• 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