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U.S. Department of Health and Human Services

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

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TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8 Back to Search Results
Model Number G8
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).Ts (technical support) explained that all samples in a cup must be pre-diluted.Area must be below 4000.Suggested customer to dilute sample and repeat.Also suggested to run old samples and controls to verify column performed due to high area of cap survey.Also change column if needed.The most probable cause of the reported event was an untrained operator attempting to run analyzer.
 
Event Description
On (b)(6) 2016 the customer reported high area on cap survey with their hlc-723g8 analyzer.Customer reported total area 7500 on survey sample.The customer is unable to run hba1c patient samples.This complaint was deemed to be reportable and classified as a level-2 event due to a potentially cap survey discrepancy.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
 
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Brand Name
TOSOH HLC-723G8 ANALYZER G8
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 Key7385931
MDR Text Key103982725
Report Number8031673-2018-03718
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 03/30/2018
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 FDA03/30/2018
Distributor Facility Aware Date04/21/2016
Device Age7 YR
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer03/30/2018
Initial Date Manufacturer Received 04/21/2016
Initial Date FDA Received03/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
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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