MAUDE Adverse Event Report: POLYMER TECHNOLOGY SYSTEMS, INC A1CNOW+; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number A1CNOW+

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

This is a home a1c test kit under brand a1cnow+.One box of test kits consistently delivers a result that is 7 or higher.One box of test kits consistently delivers a result that is 6 or higher.I did a side-by-side which was blood drawn same finger pin prick and the a1c for one is 7.4 and the other is 6.1.What is more astonishing.Is that this isn't just one kit multiple tests from the same boxes yield similar results.The whole box is off.Not just one test.This points to a bigger issue.A quick google search says it is 97.8% accurate to doctor tests.Impossible.Reference report: #mw5151894.

• Brand Name: A1CNOW+
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): POLYMER TECHNOLOGY SYSTEMS, INC
• MDR Report Key: 18777142
• MDR Text Key: 336335712
• Report Number: MW5151893
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A1CNOW+
• Device Catalogue Number: 91192
• Device Lot Number: 2224524
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: PRILOSEC.; STATIN.; WEGOVY.
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White