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

Lot Number	2303719
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer returned the a1c kit for investigation.The returned analyzer memory was downloaded and one result of 5.7% was found.It appears the customer mistook an lcd transient segment in the 5 as illuminated which gave the impression they received a value in the 9% range.An a1c test was conducted with the analyzer and pts was able to identify some transient lcd segments however the 5.0% generated by the analyzer during testing could be identified.A transient lcd segment display can occur when the user handles the analyzer roughly or places pressure on the analyzer causing damage to the lcd screen.Due to the finding from analyzer memory, this event is being reported out of an abundance of caution.
Event or Problem Description
The customer reported their analyzer lcd screen displaying four x's (all lcd segments illuminated).Additionally when testing they were able to receive a number they believed to be either 9.4% or 9.7% a1c.There were no allegations of patient/user harm.This incident is being reported out of an abundance of caution due to the investigation results when the product was returned.

• Brand Name: A1CNOW SELF CHECK
• Common Device Name: A1C ANALYZER
• 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 ; 510 oakmead pkwy; sunnyvale, CA 94085
• MDR Report Key: 17848418
• Report Number: 1836135-2023-00031
• Device Sequence Number: 7173504
• Product Code: PDJ
• UDI-Device Identifier: 00381933070019
• UDI-Public: (01)00381933070019(17)240724(10)2303719
• 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): 09/29/2023

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: 07/24/2024
• Device Lot Number: 2303719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/29/2023
• 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