ACCESS? 2 IMMUNOASSAY ANALYZER ACCESS 2 81600 N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-08 for ACCESS? 2 IMMUNOASSAY ANALYZER ACCESS 2 81600 N manufactured by Beckman Coulter Inc..

Event Text Entries

[20382252] Sample collection and centrifugation information have not been supplied to date. Per the customer, cmv-igg qc has been within the customer's established ranges. Specific qc data has not been supplied to date. Per the customer supplied documentation, a routine system check performed on (b)(6) 2011 passed within instrument specifications. Bec customer product line support (cpsl) testing of patient's sample indicate that sample was (b)(6) for cmv-igg. A clear root cause could not be determined for this event.
Patient Sequence No: 1, Text Type: N, H10


[20413490] A customer contacted beckman coulter inc. (bec) to report obtaining a (b)(6) cytomegalovirus immunoglobulin g (cmv-igg) result for one (1) patient, generated by the access 2 immunoassay analyzer. The result was not reported out of the lab. Subsequent testing of the patient's sample on the same access 2 immunoassay analyzer generated a (b)(6) result. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected to this event. This report is related to mdr 2122870-2011-02141, where the same initial reporter reported to bec an erroneous (b)(6) cmv-igg, generated by the same access 2 immunoassay analyzer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2122870-2011-02139
MDR Report Key2154616
Report Source01,05,06
Date Received2011-07-08
Date of Report2011-06-10
Date of Event2010-06-16
Date Mfgr Received2011-06-10
Device Manufacturer Date2004-08-16
Date Added to Maude2011-09-20
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 BOULEVARD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149613634
Manufacturer G1BECKMAN COULTER INC.
Manufacturer Street1000 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal Code55318
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCESS? 2 IMMUNOASSAY ANALYZER
Generic NameDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE
Product CodeOMI
Date Received2011-07-08
Model NumberACCESS 2
Catalog Number81600 N
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318


Patients

Patient NumberTreatmentOutcomeDate
10 2011-07-08

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