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

Lot Number	2312954
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving a patient result of 5.0% a1c however the result is not believable as the patient is reported to be a known diabetic.The customer also provided continuous glucose monitor results (no a1c lab available).There were no allegations of patient/user harm.
Additional Manufacturer Narrative
The customer kit was discarded and cannot be returned for investigation.In regards to the evaluation of risk, changes in pharmaceutical therapy (did not occur in this event) would be based on data in addition to the a1c such as fasting and postprandial blood glucoses, and history of hypoglycemic episodes.Qc retention was tested and measured within specification.Although risk of patient harm is low, this event is being reported to the fda out of an abundance of caution.

• Brand Name: A1CNOW SELF CHECK
• 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: 19280113
• Report Number: 1836135-2024-00016
• Device Sequence Number: 6339213
• Product Code: LCP
• UDI-Device Identifier: 00381933070019
• UDI-Public: (01)00381933070019(17)241218(10)2312954
• 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): 05/09/2024

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: 12/18/2024
• Device Lot Number: 2312954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (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