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

Model Number	1765
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1836135-2022-00042
• Device Sequence Number: 17814597
• Product Code: CGA
• UDI-Device Identifier: 00381931765016
• UDI-Public: (01)00381931765016(17)230627(10)A202
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown