MAUDE Adverse Event Report: PTS DIAGNOSTICS A1CNOW+ PROFESSIONAL TEST KIT; CLINICAL CHEMISTRY ANALYZER

Model Number	3021
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported accuracy concerns when using the a1cnow+.The customer reported receiving a result of 12.6% on the a1cnow+ compared to a lab results of 6% on the same day.There were no allegations of patient/user harm.During troubleshooting it was determined that the customer was not following the instructions as well as testing patients that were identified under the "limitations" section of the package insert.Qc retains measured within specification and the customer complaint could not be duplicated.Due to human error at complaint receipt, this item was not flagged as a pmdr until after the date by which it should have been reported.A capa has been issued accordingly.
Event or Problem Description
The customer reported accuracy concerns when using the a1cnow+.The customer reported receiving a result of 12.6% on the a1cnow+ compared to a lab results of 6% on the same day.There were no allegations of patient/user harm.

• Brand Name: A1CNOW+ PROFESSIONAL TEST KIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• MDR Report Key: 12092421
• Report Number: 1836135-2021-00017
• Device Sequence Number: 14640585
• Product Code: PDJ
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)220704(10)2023016
• 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): 06/30/2021

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 Model Number: 3021
• Device Catalogue Number: 3021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1