VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS 1286293

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-24 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS 1286293 manufactured by Ortho-clinical Diagnostics.

MAUDE Entry Details

Report Number3007111389-2019-00168
MDR Report Key9235193
Date Received2019-10-24
Date of Report2019-10-24
Date of Event2019-09-28
Date Mfgr Received2019-09-29
Device Manufacturer Date2019-01-08
Date Added to Maude2019-10-24
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 FDA3
Event Location3
Manufacturer ContactMR. JAMES A STEVENS
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO CLINICAL DIAGNOSTICS
Manufacturer StreetFELINDRE MEADOWS PENCOED
Manufacturer CityBRIDGEND, WALES CF355PZ
Manufacturer CountryUK
Manufacturer Postal CodeCF35 5PZ
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
Generic NameIN VITRO DIAGNOSTICS
Product CodeJIS
Date Received2019-10-24
Catalog Number1286293
Lot Number2510
Device Expiration Date2019-10-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-24

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