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U.S. Department of Health and Human Services

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

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BECKMAN COULTER AU680 CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Model Number AU681-10E, CHEMISTRY ANALYZER AU680 WITH ISE
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2020
Event Type  Malfunction  
Manufacturer Narrative

Beckman coulter field service engineer (fse) evaluated the au680 chemistry analyzer, and identified the failure mode as a cracked sample syringe case. The fse replaced the sample syringe case to resolve the issue. The beckman coulter internal identifier is (b)(4).

 
Event Description

The customer reported the generation of zero (0) patient results for bun (blood urea nitrogen), glu (glucose) and calc (calcium) on their au681-10e, chemistry analyzer. The erroneous patient results were not reported out of laboratory. There was no affect to patient treatment in connection to event. Quality control was within the laboratory¿s established ranges prior to event. Customer did not provide data for review.

 
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Brand NameAU680 CHEMISTRY ANALYZER
Type of DeviceANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
BECKMAN COULTER
250 s. kraemer blvd.
brea CA 92821
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
chaska, MN 55318
9523681224
MDR Report Key10475043
MDR Text Key205725935
Report Number9612296-2020-00308
Device Sequence Number1
Product Code JJE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK961274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
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
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/20/2020
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2016
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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