SYNCHRON? LX20 PRO ANALYZER 476100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-06 for SYNCHRON? LX20 PRO ANALYZER 476100 manufactured by Beckman Coulter Inc..

Event Text Entries

[2348836] A customer contacted beckman coulter inc. (bec) stating the synchron lx20 pro analyzer phosphorous module (phosm) generated 24 erroneously low patient results from (b)(6) 2011. This report is 2 of 7 reports being sent for this event and documents the patient results on (b)(6) 2011. The erroneous results were reported outside of the laboratory but there was no affect to patient treatment with regard to this event.
Patient Sequence No: 1, Text Type: D, B5


[9304150] A field service engineer (fse) went on-site (b)(6) 2011 and found that the stirrer was not spinning. Fse replaced the motor and performed maintenance on the module. Repair was verified per established procedures and results meet published performance specifications. The following mdrs are related to this event: 2050012-2011-05826; 2050012-2011-05827; 2050012-2011-05829; 2050012-2011-05830; 2050012-2011-05831; 2050012-2011-05832.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2011-05828
MDR Report Key2280869
Report Source06
Date Received2011-10-06
Date of Report2011-09-06
Date of Event2011-09-01
Date Mfgr Received2011-09-06
Device Manufacturer Date2002-08-06
Date Added to Maude2012-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. NORA ZEROUNIAN
Manufacturer Street250 S KRAEMER BLVD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149613634
Manufacturer G1BECKMAN COULTER INC.
Manufacturer Street250 S KRAEMER BLVD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal Code92821
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSYNCHRON? LX20 PRO ANALYZER
Generic NameDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE
Product CodeCEO
Date Received2011-10-06
Model NumberLX20 PRO
Catalog Number476100
Lot NumberNA
ID NumberSW VERSION 4.7
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.