MAUDE Adverse Event Report: PTS DIAGNOSTICS A1C SELF CHECK; A1C TESTING KIT

Model Number	3055
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This allegation was reported out of an abundance of caution.The kit appears to have been accepted as a return (although this product is non-returnable), then was resealed and placed for sale.The seller was notified of this occurrence.
Event or Problem Description
The customer reported that upon opening their a1c self-check kit, they observed that two lancets had been used and a blood collector that was present had been used also.The customer also noted that the box had been sliced open and taped back (used and re-sealed).The customer did not attempt to use any of the product and reported no user was hurt or injured.This allegation is being reported out of an abundance of caution.

• Brand Name: A1C SELF CHECK
• Common Device Name: A1C TESTING KIT
• Manufacturer (Section D): PTS DIAGNOSTICS; 4600 anson blvd; whitestown IN
• Manufacturer (Section G): PTS DIAGNOSTICS; 510 oakmead pkwy; sunnyvale CA
• Manufacturer Contact: brandon unruh ; 4600 anson blvd; whitestown, IN
• MDR Report Key: 16876397
• Report Number: 1836135-2023-00016
• Device Sequence Number: 12192084
• Product Code: LCP
• UDI-Device Identifier: 00681131403252
• UDI-Public: (01)00681131403252(17)240411(10)2229418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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: Lay User/Patient
• Device Expiration Date: 04/11/2024
• Device Model Number: 3055
• Device Catalogue Number: 3055
• Device Lot Number: 2229418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown