MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed error by reviewing error logs and reproduced the reported error by attempting to perform a bf probe wash run.While troubleshooting, fse found dried up wash on the sensor and also the axis screw was dirty.Fse cleaned the senor to the probe also cleaned and lubricated the axis screw to probe 3.Fse successfully reran bf probe was without errors.Quality control run was also completed without error and within acceptable range.No further action required by field service.The aia-2000 instrument is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number 10100904.There were no similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4461] b/f probe 3 home detection failure cause: the home sensor failed to activate after b/f probe 3 moved toward the home position.The measuring operation is suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to dirty bf probe sensor.

Event Description

A customer reported getting error message "4461 b/f probe 3 home detection failure" on the aia-2000 instrument.Technical support specialist (tss) instructed the customer to reboot and then try to perform an all set home command, but error persisted.The customer can see the bf probe 3 is in the downward position and tries to raise it up, but a grinding sound occurs and the error repeats.Analyzer is down.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for estradiol (e2), follicle stimulating hormone (fsh), luteinizing hormone (lh ii) and progesterone (prog ii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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 oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586-23 ; JA 1058623
• MDR Report Key: 10007937
• MDR Text Key: 222741506
• Report Number: 8031673-2020-00126
• 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: 04/27/2020

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-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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