MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) performed system troubleshooting with the customer via the telephone.The reported error 2105 was confirmed on the error log.The customer reproduced the error by priming the diluent and verified that no diluent was flowing into the diluent reservoir, only air bubbles.The customer then discovered that the tubing came off the connector at the diluent bottle.The fse had the customer reconnect the tubing and prime the diluent.The customer noted diluent now was flowing through the reservoir.Quality control (qc) was acceptable and the aia-900 instrument 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 29jun2019 to aware date (b)(6) 2020.No other similar complaints were identified during the search period.The aia-900 operator's manual states the following: [2105] diluent suction error.Cause: the tip did not touch the liquid level during suction of the diluent.A retry will be carried out, and if there is no improvement a ds flag will be attached to the measurement result.Action: if the trouble reoccurs, contact the tosoh local representatives.Check the diluent, the adjustment of the suction position, the liquid level detection sensor s053, the liquid level detection operation, and also the liquid level detection sensitivity.The probable cause of the issue is attributed to the tubing came off the diluent bottle adapter.

Event Description

A customer reported receiving error 2105 diluent suction error on the aia-900 analyzer.The diluent bottle was full.The customer performed several diluent primes, but the issue remained.An onsite service was requested.An fse was notified.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting luteinizing hormone ii (lh ii), follicle-stimulating hormone (fsh), and beta-human chorionic gonadotropin (bhcg) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• 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: 10443101
• MDR Text Key: 204044618
• Report Number: 8031673-2020-00232
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• 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