MAUDE Adverse Event Report: PTS DIAGNOSTICS A1C TEST KIT; CLINICAL CHEMISTRY ANALYZER

Lot Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted out of an abundance of caution.At the time of communication, the customer no longer had the product and could not obtain lot information.Customer noted having difficulty with test kits in the past.

Event Description

The customer reported accuracy concerns when using their a1c kit.The customer reported receiving a 7.3% on the kit and 12% from a lab.There were no allegations of patient/user harm.The incident is being reported out of an abundance of caution.

• Brand Name: A1C TEST KIT
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• MDR Report Key: 12636622
• MDR Text Key: 284118390
• Report Number: 1836135-2021-00033
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K090413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1