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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

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TOSOH CORPORATION AIA-2000 Back to Search Results
Model Number AIA-2000
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error log and was able to reproduce the issue by processing a sample.The fse resolved the issue by flushing both the main and hybrid arm nozzles and adjusted the hybrid arm z-axis to the small bottle.Additionally, the fse adjusted the hybrid arm reagent cup tip lane, standard test cup, incubator bottom, and the main arm clog sensitivity.Instrument validation was performed by processing quality control (qc) and patient samples.Qc results passed within the customer ranges.The aia-2000 analyzer returned to operation.No further action required by field service.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from installation date of 11jul2019 to aware date (b)(6) 2019.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [2070] clogging detected during specimen suction by main arm.Cause: the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution: verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube, and retry the measurement.If retry fails, contact tosoh service center or local representatives.The probable cause of the issue is attributed to clogged main and hybrid arm nozzles and misaligned z-axis to the small bottle.
 
Event Description
A customer reported receiving error message 2070, clogging detected during specimen suction by main arm, while operating on the aia-2000 analyzer.The customer stated the error was intermittent and could not analyze a sample due to the error.As a result, the customer sent the sample out to a reference laboratory for analysis.The customer noted the error also occurred when processing controls.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of intact parathyroid hormone (ipth) and follicle-stimulating hormone (fsh) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
 
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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 Key9386394
MDR Text Key219773183
Report Number8031673-2019-00480
Device Sequence Number1
Product Code KHO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/27/2019
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 NumberAIA-2000
Device Catalogue Number022100
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/01/2019
Initial Date FDA Received11/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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