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

Model Number	3021
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint is being reported out of an abundance of caution.The a1c lot had expired prior to the customer reporting the complaint.Although the lot had expired, qc retention data was available for analysis from a month prior to expiration of the lot.The qc retention measured within specifications.Customer does not have test kit available to return for evaluation.This now-expired lot of a1cnow product has had no other accuracy-related complaints lodged against it.
Event or Problem Description
The customer sent a request for training based on accuracy allegations of hba1c.Customer stated they recall one instance where the result differed by 1-2% compared to a same-day lab test.Another instance the customer recalled did not include lab result for comparison but stated that a diabetic patient was approximately 4% lower than they expected.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 46075
• MDR Report Key: 12417712
• Report Number: 1836135-2021-00027
• Device Sequence Number: 19748315
• Product Code: PDJ
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)210716(10)1931008
• 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): 09/02/2021

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: 07/16/2021
• 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: 08/04/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1