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

Model Number	3021
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that while evaluating the analyzer for use they noticed that when the results were displayed, the analyzer showed the results without a decimal point.There were no allegations of patient/user harm.The customer analyzer has not yet been returned for investigation at this time.Qc retention was evaluated and all tested analyzers had properly functioning displays.
Event or Problem Description
The customer reported that while evaluating the analyzer for use they noticed that when the results were displayed, the analyzer showed the results without a decimal point.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: 12252516
• Report Number: 1836135-2021-00021
• Device Sequence Number: 3681837
• Product Code: PDJ
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)220516(10)2022739
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/30/2021

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 Expiration Date: 05/16/2022
• Device Model Number: 3021
• Device Catalogue Number: 3021
• Device Lot Number: 2022739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1