MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Obstruction of Flow (2423)

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

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the reported error on the error log and reproduced the issue by attempting to run a control sample.The fse resolved the issue by adjusting clog parameters back into specification as it was found to be off and adjusted alignment to the diluent well.Instrument validation was performed via quality control (qc).Qc results passed within the manufacturer's published ranges.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 (b)(6) 2019 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: [2076] clogging detected at specimen cause: the negative pressure generated by suction of a (rack id, rack, position, specimen id) specimen exceeded the standard value.There is a possibility that the sampling nozzle was clogged, preventing the specified quantity of specimen suction from taking place.An sc flag will be attached to the measurement result.Action: if there is no problem with the specimen, contact the tosoh local representatives.The probable cause of the issue is attributed to clog parameters were out of specification and misalignment of the diluent well.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 2076 clogging detected at specimen, in addition to clogging detected at sds and pretreatment, on the aia-900 analyzer.The error occurred when the customer attempted to run vitamin b12 and vitamin d.As part of troubleshooting, the customer cleaned the sample probe then ran free thyroxine (ft4).The error occurred and the instrument was not operational.A field service engineer (fse) was notified.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) 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: 10353922
• MDR Text Key: 217319558
• Report Number: 8031673-2020-00217
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• 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: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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