MAUDE Adverse Event Report: POLYMER TECHNOLOGY SYSTEMS, INC. A1C NOW SELF CHECK

Catalog Number 90901

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/12/2016

Event Type  malfunction  

Event Description

Device failed internal qc test.Customer service not available.It is also poorly designed with a 50/50 chance of making a wrong choice which will cause the a1c test to not to be able to be performed.Diabetic failed a1c test.

• Brand Name: A1C NOW SELF CHECK
• Type of Device: A1C NOW SELF CHECK
• Manufacturer (Section D): POLYMER TECHNOLOGY SYSTEMS, INC.; 7736 zionsville road; indianapolis IN 46268
• MDR Report Key: 6106101
• MDR Text Key: 60289750
• Report Number: MW5066077
• Device Sequence Number: 1
• Product Code: LCP
• 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: 11/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2017
• Device Catalogue Number: 90901
• Device Lot Number: 1531548
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATENOLOL; BENICAR ; BUDESONIDE; CALCIUM; CETIRIZINE; CLONIDINE; D3; ELIQUIS; FENTANYL TRANSDERMAL; INSULIN ASPART; INSULIN GLARGINE; MONTELUKAST; PREDNISONE; RANITIDINE; RESTORIL; ROXICODONE ; SIMVASTATIN; TERAZOSIN; TESTOTERONE; WELCHOL
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 100