ACCESS? OSTASE CALIBRATOR 37305

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 2011-02-09 for ACCESS? OSTASE CALIBRATOR 37305 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2565022] ...
Patient Sequence No: 1, Text Type: D, B5


[9529770] (b)(4)
Patient Sequence No: 1, Text Type: N, H10


[17872852] A customer contacted beckman coulter inc. (bci) in regards to damaged access ostase calibrator vials, which leaked the content. Two calibrator boxes were affected by the two damaged ostase calibrator vials. The customer did not report effect to patients or end users in association to this event.
Patient Sequence No: 1, Text Type: D, B5


[17968845] An investigation of damaged ostase qc and calibrator vials was conducted at bci. It was determined that the glass vials are not compatible to freezing at -70? C.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2122870-2011-00203
MDR Report Key1982594
Report Source06
Date Received2011-02-09
Date of Report2011-01-11
Date of Event2011-01-11
Date Mfgr Received2011-01-11
Date Added to Maude2012-02-06
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
Remedial ActionOT
Previous Use Code3
Removal Correction NumberZ-2605-6-2011
Event Type3
Type of Report3

Device Details

Brand NameACCESS? OSTASE CALIBRATOR
Generic NameCALIBRATOR, PRIMARY
Product CodeJIS
Date Received2011-02-09
Model NumberNA
Catalog Number37305
Lot Number018854
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2011-02-09

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