MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During servicing, fse verified the error 2204 in the error log.Fse found that the sorter to cup assembly was out of alignment.Fse reset all sorter alignment and ran approximately 25 triiodothyronine (tt3) assay cups without any errors.Fse then ran biorad (br) quality controls (qc) with acceptable results.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 13-nov-2017 through aware date of (b)(6) 2018.There were no similar complaints found during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states the following: (2204) sorter not picked up cup- cause: the cup hold sensor s027 failed to detect a cup during a cup pickup operation.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: check the upper surface of the test cup for contamination, check the seal for curling, and so on.If the trouble occurs frequently, contact the tosoh local representatives.Check s027, the cup pickup position, and the cup pickup operation, and also check the cup control sensors s023 to s026, and the sorter scanning operation.(2205) sorter dropped cup- cause : the cup hold sensor (pressure switch) failed to detect a cup after the cup release operation was performed on the cup - tip lane or the stc lane.Sorter operation is suspended.Solution: open the sorter's door and remove the dropped cup.Close the sorter's door to resume assay.If this error occurs frequently, contact tosoh service center or local representatives.The most probable cause of reported event was the cup pickup was out of alignment.

Event Description

A customer reported a 2204 sorter not picked up cup and error message 2205 sorter dropped cup on the aia-900 instrument.The customer stated they are finding the cups in the metal tray in the sorter upon opening the sorter.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2) patient results.There was no indication of patient intervention or adverse health consequences due to the 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, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 8211086
• MDR Text Key: 133065609
• Report Number: 8031673-2018-05386
• 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
• Type of Report: Initial
• Report Date: 01/02/2019

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: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2019
• Distributor Facility Aware Date: 12/13/2018
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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