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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Model Number AU681-10E, CHEMISTRY ANALYZER AU680 WITH ISE
Device Problems High Test Results; Low Test Results
Event Date 01/09/2020
Event Type  Malfunction  
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Brand NameAU680 CLINICAL CHEMISTRY ANALYZER
Type of DeviceANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
BECKMAN COULTER
250 s. kraemer blvd.
brea CA 92821 8000
Manufacturer (Section G)
BECKMAN COULTER MISHIMA K.K.
454-32 higashino
nagaizumi-cho sunto-gun
schizuoka JP-NO TA 4
JA  JP-NOTA 41
Manufacturer Contact
harry long
1000 lake hazeltine drive
m/s r590c
chaska , MN 55318
9523681224
MDR Report Key9656098
Report Number9612296-2020-00032
Device Sequence Number1
Product CodeJJE
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAU681-10E, CHEMISTRY ANALYZER AU680 WITH ISE
Device Catalogue NumberB12188
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/09/2020
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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