MAUDE Adverse Event Report: PTS DIAGNOSTICS PTS PANELS CHOL+GLU TEST STRIPS; CLINICAL CHEMISTRY TEST STRIPS

Model Number 1765

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

Chol+glu lot a202 was packaged with an incorrect package insert (packaged with a chol+hdl package insert).Out of an abundance of caution, this event is being reported to the fda.To the best of our knowledge, there have been no adverse events reported for this lot.Additionally, a health hazard evaluation by our medical director has indicated potential for harm is unlikely.

Event Description

The customer reported that upon incoming inspection, they observed two chol+glu lot a202 boxes had a chol+hdl package insert instead.There were no allegations of patient/user harn.There were no allegations of incorrect results.

• Brand Name: PTS PANELS CHOL+GLU TEST STRIPS
• Type of Device: CLINICAL CHEMISTRY TEST STRIPS
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN 46075
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN 46075 ; 3178705610
• MDR Report Key: 15222662
• MDR Text Key: 304954625
• Report Number: 1836135-2022-00042
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00381931765016
• UDI-Public: (01)00381931765016(17)230627(10)A202
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Model Number: 1765
• Device Catalogue Number: 1765
• Device Lot Number: A202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2022
• 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: Initial
• Patient Sequence Number: 1