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

Model Number	3021
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the analyzer was not displaying results in ngsp units as printed on the analyzer.There were no allegations of patient/user harm.The analyzer has recently been received and the investigation is ongoing.
Event or Problem Description
The customer reported that the analyzer was not displaying results in ngsp units as printed on the analyzer.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: 11983789
• Report Number: 1836135-2021-00012
• Device Sequence Number: 3831613
• Product Code: PDJ
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)220910(10)2028627
• 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): 06/09/2021

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
• Device Lot Number: 2028627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1