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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

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TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE Back to Search Results
Model Number AIA-2000 ST
Device Problem Display Difficult to Read (1181)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2022
Event Type  malfunction  
Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.Fse confirmed the complaint with the customer and suspected the computer was off.Fse instructed the customer to restart the computer and the screen display turned on.Fse could not determine the cause of the reported event.The customer validated the analyzer by successfully performing daily check and quality control runs without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from (b)(6) 2021 through aware date (b)(6) 2022.There were no similar complaints identified during the search period.The most probable cause of the reported event can not be establish; error cleared upon restart of the computer.
 
Event Description
A customer reported the screen darkening on the aia-2000 analyzer, the analyzer is down.The customer reset the power and unplugged the power, but the error persists.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
 
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Brand Name
AIA-2000
Type of Device
FLUOROMETER, FOR CLINICAL USE
Manufacturer (Section D)
TOSOH HI-TEC, INC.
1-37, fukugawa minami-machi
shunan, yamaguchi 74600 42
JA  7460042
Manufacturer (Section G)
TOSOH HI-TEC, INC.
1-37, fukugawa minami-machi
shunan, yamaguchi 74600 42
JA   7460042
Manufacturer Contact
jorge porras
shiba-koen first building
3-8-2 shiba
minato-ku 10586-23
JA   1058623
6506368314
MDR Report Key15387431
MDR Text Key304364993
Report Number3004529019-2022-00162
Device Sequence Number1
Product Code KHO
UDI-Device Identifier04560189284616
UDI-Public04560189284616
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 09/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAIA-2000 ST
Device Catalogue Number022100
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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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