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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER INC.UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER

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BECKMAN COULTER INC. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER   Back to Search Results
Catalog Number 973100
Event Date 03/04/2004
Event Type  Other   Patient Outcome  Other
Event Description

A customer called beckman coulter regaridng 3 erroneously elevated accu tni results from 3 different pts that were generated by a unicel dxi instrument. Pt a had an accu tni result of 0. 711 ng/ml. Pt b had an accu tni result of 0. 792 ng/ml. Pt c had an accu tni result of 0. 965 ng/ml. The elevated result from pt a was reported out of the lab. The lab retested the pt (a) sample (on a different chemistry analyzer) and the accu tni result was 0. 002 ng/ml. The lab released a corrected lab report for pt a. The elevated accu tni result from pt b anc c were not reported out of the lab. The lab retested the pt (b) sample (on a different chemistry analyzer) and the accu tni result was 0. 176 ng/ml. The lab retested the pt (c) sample (on a different chemistry analyzer) and the accu tni result was 0. 034 ng/ml. The customer did not provide additional info regarding pt b and c. The customer did not receive any report of pt injury requiring medical intervention or change to pt treatment attributed to or connected with this event.

 
Manufacturer Narrative

(1) the customer indicated that the qc was within the expected range before and after the event occurred. (2) the customer was unable to provide any additional info regarding pt b and pt c. (3) service summary (post-event): a) the field service engineer (fse) performed a probe maintenance procedure and inspected/cleaned the wash wheel. I) the fse discovered a dirty wash wheel. Ii) the dirty wash wheel may have contributed to the erroneous results. B) the fse conducted a performance test on the instrument after the pm and the instrument passed within specifications. C) the fse stated that the instrument was performing within specifications after service. No other issues were discovered during this service call. 4) beckman coulter is unable to conclusively assign a root cause for this event. A malfunction will be assumed for the purpose of this report.

 
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Brand NameUNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
Type of DeviceDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
Baseline Brand NameUNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
Baseline Generic NameDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE
Baseline Catalogue Number973100
Baseline Device FamilyNA
Baseline Device 510(K) NumberK023764
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/17/2003
Manufacturer (Section F)
BECKMAN COULTER INC.
1000 lake hazeltine dr.
chaska MN 55318
Manufacturer (Section D)
BECKMAN COULTER INC.
1000 lake hazeltine dr.
chaska MN 55318
Manufacturer Contact
anne saber, director
11800 sw 147th avenue
mailstop: 32-c06
miami , FL 33116-9015
(305) 380 -2618
Device Event Key535490
MDR Report Key546082
Event Key518677
Report Number2122870-2004-00023
Device Sequence Number1
Product CodeJJE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 04/06/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number973100
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 04/06/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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