MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) spoke with the customer via the telephone and confirmed the error message.The customer was able to reproduce the issue by processing samples.The customer then cleaned the main arm sample nozzle and resolved the issue.The aia-2000 analyzer returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2019 to aware date (b)(6) 2020.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [2070] clogging detected during specimen suction by main arm cause: the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution: verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube and retry the measurement.If retry fails, contact tosoh service center or local representatives.The probable cause of the issue is attributed to clogged main arm sample nozzle.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported receiving error 2070 clogging detected during specimen suction by main arm on all samples run including quality control (qc), on the aia-2000 analyzer.Technical support advised the customer to use a stylet to clean the sample nozzle, but a stylet was not available.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting estradiol (e2) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10218793
• MDR Text Key: 200771671
• Report Number: 8031673-2020-00169
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2018
• 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