• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER Back to Search Results
Model Number G8
Device Problem Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2016
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2016, a field service engineer (fse) visited the client site and replaced the defective all in one computer with its reporting software.He also loaded the printer driver and the keyspan usb serial driver.He tested the unit and the data transfer capability from the g8 to the reporting software and then to the laboratory information system (lis).The fse set up the computer according to work instructions 12-css-042-0 rev 13.In addition, he removed the hard drive from the defective computer and gave it to customer so that the client disposes of it according to their protocols.No further action was required by field service.The most probable cause of the reported event was defective all in one computer.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
 
Event Description
On (b)(6) 2016, a customer reported a computer failure with their hlc-723g8 analyzer.The computer was in a repair-and-repeat startup repair cycle repeatedly.The customer was unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TOSOH HLC-723G8 ANALYZER
Type of Device
G8
Manufacturer (Section D)
TOSOH CORPORATION
shiba-koen first building
3-8-2 shiba
minato-ku, tokyo 10586 23
JA  1058623
Manufacturer (Section G)
TOSOH CORPORATION (MANUFACTURER)
shiba-koen first building
3-8-2 shiba
minato-ku, tokyo 10586 23
JA   1058623
Manufacturer Contact
doria esquivel
6000 shoreline court
suite 101
south san francisco, CA 94080
6506368123
MDR Report Key7347797
MDR Text Key103152618
Report Number8031673-2018-03172
Device Sequence Number1
Product Code LCP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/18/2018
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 NumberG8
Device Catalogue Number021560
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2018
Distributor Facility Aware Date12/16/2016
Device Age3 YR
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer03/18/2018
Initial Date Manufacturer Received 12/16/2016
Initial Date FDA Received03/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-