FDA.reportPublic FDA data

MAUDE MDR 6408200

MDR report key
6408200
Report number
1319809-2017-00020
Event key
0
Event type
3
Date of event
2017-01-26
Date received
2017-03-15
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 DGXN SLIDESIN VITRO DIAGNOSTICORTHO-CLINICAL DIAGNOSTICSLFM83433861911-0240-6317Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-150

Event Narratives#

N

Patient 1

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN PATIENT RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE FOR THE EVENT IS UNKNOWN. AN ISSUE WITH VITROS DGXN REAGENT LOT 1911-0240-6317 OR THE VITROS 5600 SYSTEM CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. IN ADDITION, IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING (CENTRIFUGATION) IS A POSSIBLE CONTRIBUTING FACTOR TO THE EVENT. THE CUSTOMER IS NOT CENTRIFUGING THE SAMPLES IN ACCORDANCE WITH THE SAMPLE COLLECTION DEVICE MANUFACTURER'S RECOMMENDATIONS AND IMPROPER PRE-ANALYTICAL SAMPLE HANDLING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. NO INFORMATION WAS PROVIDED REGARDING THE PATIENT?S MEDICATION, THEREFORE, A POSSIBLE INTERFERENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

D

Patient 1

A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS DGXN RESULTS FROM 2 SAMPLES FROM THE SAME PATIENT OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT OF 1.9 NG/ML VS. THE EXPECTED RESULT OF 2.65 NG/ML. PATIENT SAMPLE 2 RESULT OF 1.4 NG/ML VS. THE EXPECTED RESULT OF 2.04 NG/ML. THIS REPORT IS NUMBER ONE OF TWO MDR?S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THE LOWER THAN EXPECTED RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY, AND THERE WERE NO ALLEGATIONS OF PATIENT HARM. (B)(4).