MAUDE Adverse Event Report: BIOMERICA INTACT-PTH ELISA

Catalog Number	7022
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our current information demonstrates the assay is not reporting false results.We are continuing to investigate as quickly and diligently as possible to confirm the source of this issue and determine the root cause.As this time, other lots have not been implicated; however, in the interest of safety, we are including the intact-pth lots 2488, 2494, and 2494b in this notice.Not returned to manufacturer.
Event or Problem Description
The potential issue is associated with high background being observed for calibrator a.Elevated optical density (od 450 nm) of calibrator a may cause loss of separation between calibrators a and b, which may impact the assay calibration.Loss of separation has been reported from kit lot number 2488.

• Brand Name: INTACT-PTH ELISA
• Common Device Name: INTACT-PTH ELISA
• Manufacturer (Section D): BIOMERICA; 17571 von karman ave; irvine CA 92614
• MDR Report Key: 6145519
• Report Number: 2025099-2016-00001
• Device Sequence Number: 710007
• Product Code: CEW
• UDI-Device Identifier: 08305900070224
• UDI-Public: 08305900070224
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 7022
• Device Lot Number: 2488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1