FDA.reportPublic FDA data

MAUDE MDR 8552856

MDR report key
8552856
Report number
8031673-2019-00132
Event key
0
Event type
3
Date received
2019-04-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MS. DORIA ESQUIVEL
Address
SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 10586 JA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOSOH HLC-723G8 ANALYZER G8G8TOSOH CORPORATIONLCPG8021560* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-250

Event Narratives#

N

Patient 1

FIELD SERVICE ENGINEERS (FSE) EVALUATED THE FOUR (4) ANALYZERS AT THE CUSTOMERS' SITES. THE FSES WERE ABLE TO REPLICATE THE ERROR MESSAGES DESCRIBED IN THE REPORTED EVENTS. THE FSES REPLACED SOLENOID VALVES AND RETURNED THE G8 ANALYZERS INTO OPERATIONAL STATUS. THREE (3) OF THE 4 SOLENOID VALVES WERE RETURNED TO THE TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION (ISC). IN ONE (1) OF THE THREE (3) RETURNED SOLENOID VALVES, ISC WAS ABLE TO REPLICATE THE REPORTED DUE TO THE SOLENOID VALVE NOT OPENING AND CLOSING PROPERLY. IN TWO (2) OF THE THREE (3) RETURNED SOLENOID VALVES, ISC WAS NOT ABLE TO REPLICATE THE REPORTED EVENTS.

D

Patient 1

THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS ON THE G8 ANALYZER. THE REVIEW OF THESE EVENTS INDICATED THAT THE G8 ANALYZERS EXPERIENCED PRESSURE ERROR MESSAGES, WHICH CAUSED DELAYED REPORTING OF HEMOGLOBIN A1C (HBA1C) PATIENT RESULTS. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE TWO (2) EVENTS INVOLVED PATIENT SAMPLES WITH NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAYED REPORTING TEST RESULTS. NONE OF THESE EVENTS NECESSITATED REMEDIAL ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH.