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	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint is being reported out of an abundance of caution based on the customer provided results.There were no allegations of patient/user harm.Qc retention was investigated.The qc retention measured within specifications.The customer has not yet responded to attempts to have product returned for investigation.This lot of a1cnow product has had no other accuracy-related complaints lodged against it.
Event or Problem Description
The customer reported a patient who tested at 7.6% hba1c on the a1c test kit and went to the doctor three days later and received a result of 11.6% hba1c.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: 12490600
• Report Number: 1836135-2021-00030
• Device Sequence Number: 14571082
• Product Code: LCP
• UDI-Device Identifier: 00381933021011
• UDI-Public: (01)00381933021011(17)221015(10)2028638
• 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): 09/17/2021

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: 10/15/2022
• Device Model Number: 3021
• Device Catalogue Number: 3021
• Device Lot Number: 2028638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1