FDA.reportPublic FDA data

MAUDE MDR 6718604

MDR report key
6718604
Report number
1319809-2017-00132
Event key
0
Event type
3
Date of event
2017-06-19
Date received
2017-07-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
105
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 DGXN SLIDESIN VITRO DIAGNOSTICORTHO-CLINICAL DIAGNOSTICSLFM83433861913-0242-0036Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-170

Event Narratives#

N

Patient 1

THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS DGXN RESULT WAS OBTAINED WHEN TESTING A PROFICIENCY SAMPLE USING A VITROS 4600 CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ASSIGNABLE CAUSE OF THE EVENT. A REVIEW OF HISTORICAL QUALITY CONTROL DATA CONCLUDED THAT THERE IS NO ISSUE WITH THE VITROS DGXN SLIDE LOT BASED ON THE DGXN QC PERFORMANCE. THE ALT AND DGXN WITHIN-RUN MARKER PRECISION RESULTS WERE ACCEPTABLE INDICATING THE VITROS 4600 CHEMISTRY SYSTEM WAS PERFORMING AS INTENDED. HOWEVER, AN ORTHO FE HAS BEEN REQUESTED ON SITE DUE TO CONDITION CODE U90-382 (IR WASH ERROR) THAT OCCURRED ONE TIME DURING THE DGXN PRECISION TESTING. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR TO THIS EVENT. THE (B)(6) SAMPLES ARE FROM THE 2017 C A SURVEY, WERE INITIALLY PROCESSED (B)(6) 2017 AND STORED FROZEN. THE RECOMMENDED OPEN STORAGE IS 2-8 C FOR 7 DAYS. LONG TERM STORAGE AND STABILITY FOR THESE CAP FLUIDS IS UNKNOWN, THEREFORE, IMPROPER FLUID HANDLING (STORAGE) CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

D

Patient 1

THE CUSTOMER OBSERVED A LOWER THAN EXPECTED VITROS DGXN RESULT WHEN TESTING A (B)(6) PROFICIENCY SAMPLE ON A VITROS 4600 CHEMISTRY SYSTEM. CAP SAMPLE DGXN RESULT 1.7 NG/ML VERSUS EXPECTED DGXN RESULT 2.81 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE VITROS DGXN RESULT WAS OBTAINED WHEN TESTING A PROFICIENCY SAMPLE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. (B)(4).