MAUDE Adverse Event Report: PTS DIAGNOSTICS A1CNOW SELF CHECK; CLINICAL CHEMISTRY ANALYZER

Model Number 3070

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

The customer reported having trouble using their a1c kit.During troubleshooting the customer stated they have one analyzer but two cartridges with different codes.One matches the analyzer, the other does not.There were no allegations of patient/user harm.There were no allegations of incorrect results.This event is being reported out of an abundance of caution due to the customers report of having mismatched cartridges.

Manufacturer Narrative

The customer did not receive a result or make a medical decision based on any testing using these components.This report is being submitted out of an abundance of caution.Pts packaged lot with w0 lot code, performed line clearance and then packaged lot with x0 code followed by another line clearance before packaging lot with code y0.The materials from lots with codes w0 and y0 should not have been intermingled based on manufacturing processes.No other complaints have been alleged against mixing of these lot codes.To further examine the customer's allegation, we examined the codes printed on retained test cartridges (6 each) and analyzers (3 each).All cartridges and analyzers used across testing possessed the code w0 as expected.

• Brand Name: A1CNOW SELF CHECK
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• Manufacturer (Section G): PTS DIAGNOSTICS; 510 oakmead pkwy; sunnyvale CA
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN 46075 ; 3178705610
• MDR Report Key: 13296944
• MDR Text Key: 287276808
• Report Number: 1836135-2022-00008
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 00381933070019
• UDI-Public: (01)00381933070019(17)220106(10)2107749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2022
• Device Model Number: 3070
• Device Catalogue Number: 3070
• Device Lot Number: 2107749
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1