MAUDE Adverse Event Report: PTS DIAGNOSTICS A1CNOW SELF CHECK; A1C CLINICAL ANALYZER

Lot Number	2320644
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported washing their face after exposure which is the proper measure per the safety data sheet.The customer did not require further aid.Risk of exposure is limited to irritation of the site (particularly on prolonged contact).This event is being reported out of an abundance of caution due to the exposure area.Qc retention components were inspected.No manufacturing defects were observed and no fluid leak or splash was observed during testing.
Event or Problem Description
The customer reported that when attempting to perform a test with their a1c kit, the shaker solution splashed onto their face upon collector insertion.There were no allegations of patient/user harm during or after the incident.

• Brand Name: A1CNOW SELF CHECK
• Common Device Name: A1C CLINICAL ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown
• Manufacturer (Section G): PTS DIAGNOSTICS; 510 oakmead pkwy; sunnyvale CA 94085
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN ; 3178705610
• MDR Report Key: 19670761
• Report Number: 1836135-2024-00024
• Device Sequence Number: 15194868
• Product Code: PDJ
• UDI-Device Identifier: 00381933070019
• UDI-Public: (01)00381933070019(17)250222(10)2320644
• 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): 07/03/2024

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: 02/22/2025
• Device Lot Number: 2320644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 07/03/2024
• 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