FDA.reportPublic FDA data

MAUDE MDR 8387356

MDR report key
8387356
Report number
1319809-2019-00012
Event key
0
Event type
3
Date of event
2019-01-18
Date received
2019-03-04
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 LACTATE SLIDESIN VITRO DIAGNOSTICSORTHO-CLINICAL DIAGNOSTICSKHP81501123530-0103-5136Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-040

Event Narratives#

N

Patient 1

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS LAC RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROL LOT 47970, TESTED WITH VITROS LAC SLIDE LOT 3530-0103-5136 ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE AN ASSIGNABLE CAUSE. THE EVENT SUDDENLY OCCURRED ON (B)(6) 2019. BOTH ACCEPTABLE AND UNACCEPTABLE VITROS LAC QUALITY CONTROL RESULTS WERE OBTAINED FROM TWO DIFFERENT AFFECTED CARTRIDGES, INDICATING THE VITROS LAC SLIDES IN USE DID NOT LIKELY CONTRIBUTE TO THE EVENT. IN ADDITION, ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED FOR 8 DAYS PRIOR TO THE EVENT, USING THE SAME CALIBRATION EVENT, INDICATING THE EVENT WAS NOT CALIBRATION DRIVEN. ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED AFTER THE EVENT OCCURRED, THROUGH THE PRESENT, WITH NO ACTIONS TAKEN TO IMPROVE PERFORMANCE. THIS INDICATES THAT VITROS LAC SLIDE LOT 3530-0103-5136 WAS PERFORMING AS INTENDED ON THE VITROS 5600 INTEGRATED SYSTEM SINCE THE EVENT THAT OCCURRED ON (B)(6) 2019. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS LAC SLIDE LOT 3530-0103-5136.

D

Patient 1

A CUSTOMER REPORTED HIGHER THAN EXPECTED QUALITY CONTROL (QC) RESULTS OBTAINED USING VITROS CHEMISTRY PRODUCTS LACTATE (LAC) SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. NON-VITROS BIORAD QUALITY CONTROL LOT 47970. L1 VITROS LAC RESULT OF 2.10 MMOL/L VS. THE EXPECTED RESULT OF 1.43 MMOL/L. L2 VITROS LAC RESULTS OF 4.43, 4.44, AND 4.41 MMOL/L VS. THE EXPECTED RESULT OF 3.49 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED VITROS LAC RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS AND THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER 4 OF 4 MDR?S FOR THIS EVENT. FOUR (4) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 4 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).