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 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the issue on the error log and replicated the issue by verifying the sorter and stc lane alignment.The fse realigned the sorter and stc lane cup transfer which resolved the issue.Instrument performance test was completed and passed.And controls were within the acceptable range.The aia-2000 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-2000 operator's manual states the following: [2145] failed to detect cup from sorter on stc lane cause: the cup sensor failed to detect a cup from the sorter on the stc lane.If retry fails, the measurement result will be flagged (mf flag).Solution: contact (b)(6) or local representatives.The probable cause of the issue is attributed to misalignment of the stc lane.

Event Description

A customer reported error 2145 failed to detect cup from sorter on stc lane on the aia-2000 analyzer.While troubleshooting, several dropped stc cups were discovered in the stc lane area.The customer removed the cups and also removed stc cups dropped inside the sorter.However, the issue continued.An fse was dispatched.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth), progesterone ii (prog ii), and 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: 10508783
• MDR Text Key: 221563740
• Report Number: 8031673-2020-00249
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 022101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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