MAUDE Adverse Event Report: TOSOH AIA 025261; THYROID STIMULATING HORMONE ASSAY

Model Number AIA-900

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to a complaint of failed api on the aia-900 analyzer.At the customer site, the field service found the diluent pump to be weak and replaced it.After replacement, the diluent flowed as expected.This indicates a proficiency failure due to a weak diluent pump causing inadequate delivery.

Event Description

The api failed three times has been determined to be a reportable malfunction to the fda based on failed proficiency testing.

• Brand Name: 025261
• Type of Device: THYROID STIMULATING HORMONE ASSAY
• Manufacturer (Section D): TOSOH AIA; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH AIA; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12365887
• MDR Text Key: 271945057
• Report Number: 3004529019-2021-00015
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863859
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Lot Number: B317441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1