FDA.reportPublic FDA data

MAUDE MDR 8339392

MDR report key
8339392
Report number
1319808-2019-00006
Event key
0
Event type
3
Date of event
2019-01-16
Date received
2019-02-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JAMES A STEVENS
Address
100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US
Phone
585-585-5854
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITROS CHEMISTRY PRODUCTS TOBRA REAGENTIN-VITRO DIAGNOSTICORTHO-CLINICAL DIAGNOSTICSLDO68017121513-05-6924Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-140

Event Narratives#

N

Patient 1

THE INVESTIGATION CONCLUDED THAT HIGHER THAN EXPECTED VITROS TOBRAMYCIN (TOBRA) RESULTS WERE OBTAINED FROM A HIGH LEVEL CALIBRATOR FLUID PROCESSED USING A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATOR FLUID WAS DILUTED AND TESTED AS PART OF AN INVESTIGATION FOR AN ISSUE WITH HIGH DILUTED TOBRA RESULTS ON MULTIPLE CAP PROFICIENCIES. THE HIGHER THAN EXPECTED RESULTS FOR DILUTED SAMPLES HAVE OCCURRED ACROSS MULTIPLE VITROS TOBRA LOTS OF REAGENT OVER TIME. ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS TOBRA REAGENT LOT 1513-03-5038. THE ASSIGNABLE CAUSE IS NOT LIKELY TO BE RELATED TO A SPECIFIC REAGENT LOT OR CALIBRATION EVENT. AN INSTRUMENT ISSUE OR AN ISSUE RELATED TO THE ON-BOARD DILUTION CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

D

Patient 1

A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS TOBRAMYCIN (TOBRA) RESULTS FROM A HIGH LEVEL CALIBRATOR FLUID PROCESSED USING A VITROS 5600 INTEGRATED SYSTEM. CALIBRATOR KIT LOT 1428, BOTTLE 6 RESULTS 14.0, 14.3 UG/ML VERSUS AN EXPECTED RESULT OF 10.4, 10.6 UG/ML. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED FROM THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT DEFINITIVELY CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).