MAUDE Adverse Event Report: BIOTEK INSTRUMENTS, INC. ELX50; STRIP WASHER 8 WELL

Model Number ELX508

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

The united states of america customer reported some of the tubes on their manifold are not dispensing.There was no direct or indirect patient harm or user harm reported.The instrument has not been serviced yet as the customer has not responded to the service quote.The customer noted there was a concern the test results were not correct.3 good faith effort attempts were made to the customer to gather more information with no response.No additional information has been made available.If additional information is received a follow-up report will be submitted.

Manufacturer Narrative

No patient or user harm was indicated.If additional information is received a follow-up report will be submitted.A1-a6: patient information has not been provided by the user.

• Brand Name: ELX50
• Type of Device: STRIP WASHER 8 WELL
• Manufacturer (Section D): BIOTEK INSTRUMENTS, INC.; 100 tigan street; winooski VT 05404
• Manufacturer (Section G): AGILENT TECHNOLOGIES, INC. (FORMERLY BIOTEK); 100 tigan street; winooski VT 05404
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 17398549
• MDR Text Key: 320670143
• Report Number: 0001217454-2023-00001
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

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
• Device Operator: Health Professional
• Device Model Number: ELX508
• Device Catalogue Number: ELX508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1