VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[96056430] The investigation confirmed that lower than expected myoglobin results were obtained from a non-vitros quality control fluid using vitros immunodiagnostics products myoglobin reagent pack lot 1280 on vitros 5600 integrated systems s/ns 56002071 and 56002072. A definitive assignable cause for the event could not be determined. As a within-run precision test of the vitros 5600 integrated systems was not performed, it cannot be confirmed that the instruments were operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the events. The most likely assignable cause for the lower than expected vitros myog qc fluid results using the non-vitros biorad qc fluid lot 23635 is a sub optimal calibration event as re-calibration using the same lot of calibrators has resolved the issue for the customer.
Patient Sequence No: 1, Text Type: N, H10


[96056431] The customer observed lower than expected myoglobin results obtained from a non-vitros quality control (qc) fluid using vitros immunodiagnostic products myoglobin reagent pack on a vitros 5600 integrated system. Biorad level 1 lot 23635 results 109 and 109 ng/ml versus customer established mean 123 ng/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected and the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number two of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007111389-2017-00203
MDR Report Key7126030
Date Received2017-12-18
Date of Report2018-12-17
Date of Event2017-11-21
Date Mfgr Received2017-12-21
Device Manufacturer Date2017-09-13
Date Added to Maude2017-12-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
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 MYOGLOBIN REAGENT PACK
Generic NameIN-VITRO DIAGNOSTIC
Product CodeDDR
Date Received2017-12-18
Catalog Number6801042
Lot Number1280
ID Number10758750001019
Device Expiration Date2018-08-19
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 2017-12-18

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