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

Lot Number	A329
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not respond to multiple follow-up attempts to perform retesting with their product.The customer did not return product for evaluation.Qc retention was tested and measured within specification.This event is being reported to the fda out of an abundance of caution.
Event or Problem Description
The customer reported that two patients experienced high glucose recovery when testing with the product.One patient reported that the value was high but is unsure of their expected value.The second patient reported the value received (241 mg/dl) was high so they tested themselves on their cgm they were wearing and received 141 mg/dl.There were no allegations of patient/user harm.

• Brand Name: CHOL+GLU TEST STRIPS
• Common Device Name: CLINICAL CHEMISTRY TEST STRIPS
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer (Section G): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN ; 3178705610
• MDR Report Key: 19723732
• Report Number: 1836135-2024-00026
• Device Sequence Number: 8190570
• Product Code: CGA
• UDI-Device Identifier: 00381931765016
• UDI-Public: (01)00381931765016(17)250303(10)A329
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162282
• 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): 07/11/2024

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: 03/03/2025
• Device Lot Number: A329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown