FDA.reportPublic FDA data

MAUDE MDR 8339059

MDR report key
8339059
Report number
1319809-2019-00005
Event key
0
Event type
3
Date of event
2019-01-17
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 BUBC SLIDESIN VITRO DIAGNOSTICSORTHO-CLINICAL DIAGNOSTICSCIG83830510232-0414-0058Y Y

Patients#

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

Event Narratives#

N

Patient 1

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS BU RESULTS FROM A NEONATAL PATIENT SAMPLE WERE ATTAINED USING VITROS CHEMISTRY PRODUCTS BUBC SLIDES IN COMBINATION WITH A VITROS 250 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BASED ON QUALITY CONTROL DATA, THERE IS NO INDICATION THAT A VITROS BUBC REAGENT ISSUE CONTRIBUTED TO THE EVENT. FURTHERMORE, ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS BUBC SLIDES LOT 0232-0414-0058. A TRANSIENT REAGENT ISSUE RELATED TO A SPECIFIC CARTRIDGE OR SERIES OF CARTRIDGES CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR AS MULTIPLE LOWER THAN EXPECTED RESULTS WERE REPORTED CONSECUTIVELY. PRE-SERVICE WITHIN RUN PRECISION TESTING DID NOT MEET EXPECTATIONS. A FIELD ENGINEER WENT TO THE SITE AND PERFORMED MULTIPLE SERVICE ACTIONS INCLUDING INCUBATOR CLEANING AND SEVERAL ADJUSTMENTS. AFTER SERVICE ACTIONS WERE COMPLETED, THE CUSTOMER REPORTED THE INSTRUMENT HAD BEEN RETURNED TO EXPECTED OPERATION. AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT.

D

Patient 1

A CUSTOMER REPORTED LOWER THAN EXPECTED VITROS BU RESULTS OBTAINED FROM A NEONATAL PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS BUBC SLIDES IN COMBINATION WITH A VITROS 250 CHEMISTRY SYSTEM. VITROS BU RESULTS OF