ACTIVE? IGF-BP3 RIA DSL-6600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-07 for ACTIVE? IGF-BP3 RIA DSL-6600 manufactured by Beckman Coulter Inc..

Event Text Entries

[1498366] A customer reported to beckman coulter inc. , (bci) that samples gave higher than expected results using the dsl igf-bp3 methodology. The results are discordant to the normal values described in the kit insert and igf-1 status. The results were reported outside of the lab. Patients underwent further diagnostic testing.
Patient Sequence No: 1, Text Type: D, B5


[8566699] A clear root cause for this event has not been determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1628193-2010-00002
MDR Report Key1677583
Report Source05
Date Received2010-05-07
Date of Report2010-05-07
Date of Event2010-02-10
Date Mfgr Received2010-02-12
Date Added to Maude2011-12-23
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 Street445 WEST MEDICAL CENTER BLVD.
Manufacturer CityWEBSTER TX 77598
Manufacturer CountryUS
Manufacturer Postal Code77598
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIVE? IGF-BP3 RIA
Generic NameINSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3
Product CodeCFL
Date Received2010-05-07
Model NumberNA
Catalog NumberDSL-6600
Lot Number100115
Device AvailabilityN
Device AgeDA
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 2010-05-07

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