ACTIVE? INHIBIN A ELISA, 4X96 WELLS DSL-10-28100-4

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 2011-04-07 for ACTIVE? INHIBIN A ELISA, 4X96 WELLS DSL-10-28100-4 manufactured by Beckman Coulter Inc..

Event Text Entries

[1855897] A customer contacted beckman coulter inc (bci) stating that the data generated during lot to lot correlations for the active inhibin a elisa methodology did not meet the laboratory's expectation criteria of less than 10% difference for the sample comparison. The customer indicated that the lot is exhibiting a positive bias when compared to older lot samples recoveries. The customer also indicated that the comparison assay analysis was performed on multiple days and not a true side by side analysis. The original analysis was performed on (b)(6) 2011 with the old lot number, followed by the comparative analysis on (b)(6) 2011 respectively with the new lot number. Correlation analysis data report provided, illustrated fifty five (55) comparison data points analyzed on (b)(6) 2011, demonstrating a 15% positive bias between the old and the new lot. Additional correlation analysis data report provided, illustrated fifty five (55) comparison data points analyzed on (b)(6) 2011, demonstrating a 12% positive bias between the old and the new lot. The studies did not include any patient samples that were used for reporting. The customer did not report affect to the patient or user attributed or connected to this event.
Patient Sequence No: 1, Text Type: D, B5


[9081965] Sample collection and centrifugation data was not supplied. Sample storage including conditions for time frame between lot correlation evaluations was not supplied. Qc data points identified that the qc recovery was within the established ranges. However, qc was out of range at the end of the plate assay run performed on (b)(6) 2011. The customer indicated that the unit associated with this event was performing within the laboratory's specifications. Symptom reported is relative to customer's expectations of % difference between lots which was not related. Internal investigation is pending to date, and no clear root cause has been determined thus far.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2122870-2011-00911
MDR Report Key2042765
Report Source06
Date Received2011-04-07
Date of Report2011-02-18
Date of Event2011-01-24
Date Mfgr Received2011-02-18
Device Manufacturer Date2010-07-22
Date Added to Maude2011-10-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
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 Street445 WEST MEDICAL CENTER BLVD.
Manufacturer CityWEBSTER TX 77598
Manufacturer CountryUS
Manufacturer Postal Code77598
Single Use3
Previous Use Code3
Removal Correction Number2050012-03/31/2011-014C
Event Type3
Type of Report3

Device Details

Brand NameACTIVE? INHIBIN A ELISA, 4X96 WELLS
Generic NameINHIBIN A ENZYME-LINKED IMMUNOSORBENT (ELISA)
Product CodeNDR
Date Received2011-04-07
Model NumberNA
Catalog NumberDSL-10-28100-4
Lot Number091174
Device Expiration Date2011-10-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address445 WEST MEDICAL CENTER BLVD. WEBSTER TX 77598 US 77598


Patients

Patient NumberTreatmentOutcomeDate
10 2011-04-07

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