ACTIVE? INHIBIN A ELISA, 4X96 WELLS N/A 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 01,05 report with the FDA on 2011-06-01 for ACTIVE? INHIBIN A ELISA, 4X96 WELLS N/A DSL-10-28100-4 manufactured by Beckman Coulter Inc..

Event Text Entries

[2147018] A customer contacted beckman coulter inc (bci) to report observing higher than expected dsl inhibin a manual elisa methodology results for two samples. Per customer's sop all results which do not fir the clinical picture of a patient is retested. The samples were repeated on (b)(6) 2010. Subsequent analysis was performed utilizing hbr blocking tubes which resulted in lower dose recovery. The customer indicated that the lower dose recovery of immeasurable inhibin a obtained post hbr blocking tubes analysis was expected based on the patients' clinical picture. The results were not reported out of the laboratory. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected with this event.
Patient Sequence No: 1, Text Type: D, B5


[9022870] Samples collection and centrifugation data was not supplied. Samples storage including conditions for time frame between initial testing and subsequent hbr blocking analysis was not provided. Calibration curves parameters and qc data was not supplied. Per customer, the assays were performed on a manual elisa assay platform. Specific equipment maintenance records were not supplied. Service was not dispatched. A heterophile interference phenomenon was not confirmed by bci for this event. A definitive root cause has not been determined to date for this event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2122870-2011-01621
MDR Report Key2110694
Report Source01,05
Date Received2011-06-01
Date of Report2011-04-28
Date of Event2010-10-18
Date Mfgr Received2011-04-28
Device Manufacturer Date2010-10-19
Date Added to Maude2012-04-10
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 Street1000 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal Code55318
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameACTIVE? INHIBIN A ELISA, 4X96 WELLS
Generic NameINHIBIN A ENZYME-LINKED IMMUNOSORBENT (ELISA),
Product CodeNDR
Date Received2011-06-01
Model NumberN/A
Catalog NumberDSL-10-28100-4
Lot Number090498, 091055, 090798
ID NumberN/A
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 2011-06-01

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