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U.S. Department of Health and Human Services

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

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TOSOH HI-TEC, INC. AIA-2000 ST; FLUOROMETER, FOR CLINICAL USE Back to Search Results
Model Number AIA-2000 ST
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
An investigation was performed in response to a complaint of issues with the query on the aia-2000 analyzer.The device was being used for diagnosis during the complaint event.Further investigation is in progress.
 
Event Description
The customer reported having issues with the query on the aia-2000 analyzer.The customer has a beaker lis and stated that the aia-2000 is the only analyzer that will not query a sample put in the system over 24 hours.The customer put orders in the system, and if the sample is not put on the analyzer within 24 hours, it times out and will not run.Field service was notified.A field service engineer (fse) was dispatched to address the reported issue.There was a delay in reporting intact parathyroid hormone (ipth) patient results.However, there was no patient intervention or adverse health consequences due to the event.
 
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Brand Name
AIA-2000 ST
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
bernadette o connell
shiba-koen first building
3-8-2 shiba
minato-ku 10586-23
JA   1058623
6506368143
MDR Report Key12411663
MDR Text Key271947514
Report Number3004529019-2021-00024
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 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
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 Received08/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2017
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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