ACCESS? THYROGLOBULIN 33860

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-24 for ACCESS? THYROGLOBULIN 33860 manufactured by Beckman Coulter.

Event Text Entries

[19398634] There is no indication the access thyroglobulin device was returned for evaluation. In conclusion, a definitive cause of the incident could not be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10


[19557766] The customer reported positive thyroglobulin (access thyroglobulin) results involving the access thyroglobulin assay used in conjunction with the unicel dxi 800 access immunoassay system. Results were negative through an alternate methodology. The patient samples were also tested through mass spectrometry which also produced negative results and correlated with the patient's clinical picture. The original results were released from the laboratory. There was no patient injury or change in patient treatment associated with this event. The customer had validated the access thyroglobulin assay to perform at levels below those stated in the ifu (instructions for use). The customer also performed a correlation study. Within it, there were examples of recovery outside of the expected recovery per the ifu. Data analysis indicates that all measured system parameters had been within specifications. No system issues were reported. The instrument was in normal operation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2122870-2013-01123
MDR Report Key3537057
Report Source05,06
Date Received2013-12-24
Date of Report2013-12-02
Date of Event2013-12-02
Date Mfgr Received2013-12-02
Device Manufacturer Date2013-10-01
Date Added to Maude2014-04-02
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. DUNG NGUYEN
Manufacturer Street250 S. KRAEMER BLVD.
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149614941
Manufacturer G1BECKMAN COULTER
Manufacturer Street1000 LAKE HAZELTINE DRIVE
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal Code55318
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCESS? THYROGLOBULIN
Generic NameSYSTEM,TEST,THYROGLOBULIN
Product CodeMSW
Date Received2013-12-24
Model NumberNA
Catalog Number33860
Lot Number330925
ID NumberNA
Device Expiration Date2015-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer Address250 S. KRAEMER BLVD. BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2013-12-24

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