FDA.reportPublic FDA data

MAUDE MDR 7707136

MDR report key
7707136
Report number
1319808-2018-00020
Event key
0
Event type
3
Date of event
2018-06-13
Date received
2018-07-20
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 VALP REAGENTIN VITRO DIAGNOSTICORTHO-CLINICAL DIAGNOSTICSLEG68017102511-25-5974Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-200

Event Narratives#

N

Patient 1

THE INVESTIGATION HAS DETERMINED THAT A HIGHER THAN EXPECTED VITROS VALP RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE DURING A PATIENT CORRELATION ON A VITROS 5600 SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS CALIBRATION TO CALIBRATION VARIABILITY. THE CUSTOMER PROCESSED A LOT TO LOT PATIENT COMPARISON AND NOTED A SHIFT LOW IN VALP RESULTS GENERATED USING THE NEW VALP REAGENT LOT. THE CUSTOMER RECALIBRATED VITROS VALP LOT 2511-25-5974 AND REPEATED THE PATIENT COMPARISON USING THE SAME VITROS 5600 SYSTEM AND AN ALTERNATE VITROS 5600 SYSTEM IN THE LABORATORY. THE RECALIBRATION OF VITROS VALP LOT 2511-25-5974 RESULTED IN ACCEPTABLE QUALITY CONTROL AND PATIENT CORRELATION RESULTS ON BOTH VITROS 5600 SYSTEMS. THIS WOULD INDICATE THAT, WHILE ACCEPTABLE, THE CALIBRATION PERFORMED ON 12 JANUARY 2018 WAS DIFFERENT ENOUGH FROM THE NEW CALIBRATION TO BE CONSIDERED SUBOPTIMAL. THE INVESTIGATION CONCLUDED THE ASSIGNABLE CAUSE WAS CALIBRATION TO CALIBRATION VARIABILITY. THERE WAS NO INDICATION THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. IN ADDITION, A COMPLAINT REVIEW OF VALP LOT 2511-25-5974 DID NOT INDICATE A REAGENT ISSUE. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP LOT 2511-25-5974. THE MDR IS BEING SUBMITTED AFTER THE 30 DAY REPORTING DATE DUE TO A TECHNICAL ISSUE WITH ORTHO?S MDR REPORTING SYSTEM. ORTHO WAS UNABLE TO ELECTRONICALLY SUBMIT MDRS FROM 5 JULY 2018 ? 19 JULY 2018.

D

Patient 1

A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS VALP RESULT FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 SYSTEM DURING A PATIENT CORRELATION. PATIENT 4 SAMPLE, VITROS VALP (2511-25-5974) RESULT 403 UMOL/L VERSUS THE VITROS VALP (LOT 2511-25-6393) RESULTS 332 AND 331 UMOL/L. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE MEDICAL ACTION IF NOT DETECTED. THE HIGHER THAN EXPECTED VITROS VALP RESULT WAS NOT REPORTED FROM THE LABORATORY. ORTHO WAS NOT MADE AWARE OF ANY ERRONEOUS PATIENT SAMPLE RESULTS THAT WERE OBTAINED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).