MAUDE Adverse Event Report: BIOMERICA INTACT-PTH ELISA

Catalog Number 7022

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2016

Event Type  malfunction  

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 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
• Type of Device: INTACT-PTH ELISA
• Manufacturer (Section D): BIOMERICA; 17571 von karman ave; irvine CA 92614
• Manufacturer (Section G): BIOMERICA; 17571 von karman ave; irvine CA 92614
• Manufacturer Contact: louise miyamoto ; 17571 von karman ave; irvine, CA 92614 ; 9496452111
• MDR Report Key: 6145519
• MDR Text Key: 61452795
• Report Number: 2025099-2016-00001
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 08305900070224
• UDI-Public: 08305900070224
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K974306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 7022
• Device Lot Number: 2488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1