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 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse confirmed the complaint by reviewing the error log.The problem was reproduced by trying to run a patient sample.The complaint was resolved by correcting the main arm tip set position alignment.The instrument was validated by running quality controls (qc) and patient samples; results passed and were within published ranges.No further action required by field service.The aia-2000 instrument is functioning as expected.The aia-2000 serial number (b)(4), was installed at the account on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from (b)(6)2019 through aware date 16october2019.There was one other complaint identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: 4223 main arm z-axis home overrun cause: the home sensor activated improperly after movement of the main arm z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.2151 hybrid arm /cup transfer cup pickup failure cause: the cup-gripping sensor failed to detect a cup after the cup pickup operation was performed.Solution: contact tosoh service center or local representatives.4224 interference of dispensing nozzle z-axis of main arm cause: there is a possibility that the dispensing nozzle was interfered with an obstacle such as cap of primary tube.The measurement result will be flagged with the ss flag.Or a command or adjustment value (p05, 191-210) was given for movement beyond the maximum movable distance of the main arm z-axis in the maintenance operation.Solution : remove an obstacle such as cap of primary tube, if any.The probable cause of the reported event was due to a misalignment of the main arm.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 getting error messages 4223 main arm z-axis home overrun, 2151 hybrid arm /cup transfer cup pickup failure, and 4224 interference of dispensing nozzle z-axis of main arm on the aia-2000 instrument.A tech support specialist (tss) instructed the customer to open the instrument; the customer found a tip stuck on the nozzle.The customer removed the tip and performed an all set home and a reset.The customer ran the calibration and called back to report that they received error 4224 again.The customer cleaned the sample nozzle as it was sticky.The customer tried running some controls however the error 4224 occurred again.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of intact parathyroid hormone (ipth) patient results.There was no indication of patient intervention or adverse health consequences due to the 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: ms. oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9312447
• MDR Text Key: 194605331
• Report Number: 8031673-2019-00449
• 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: 11/12/2019

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-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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