FDA.reportPublic FDA data

MAUDE MDR 5357561

MDR report key
5357561
Report number
1319809-2016-00002
Event key
0
Event type
3
Date of event
2015-12-08
Date received
2016-01-11
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 AMON SLIDESIN-VITRO DIAGNOSTICORTHO-CLINICAL DIAGNOSTICSJID17218691015-0238-1246Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-01-110

Event Narratives#

N

Patient 1

THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULT WAS OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. HOWEVER, USER ERROR DUE TO IMPROPER USE OF REAGENT PAST ITS ONBOARD STABILITY IS A LIKELY ASSIGNABLE CAUSE. BASED ON THE INFORMATION AVAILABLE, A VITROS INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE.

D

Patient 1

THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. QC LPV II VITROS AMON RESULT OF 133.7 MOL/L VS. EXPECTED RESULT 176.9 MOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION, SHOULD THEY OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER STATED THAT NO VITROS AMON PATIENT SAMPLES TESTED DURING THE TIME FRAME OF THE EVENT WERE IN QUESTION. HOWEVER, THE INVESTIGATION CANNOT RULE OUT THAT PATIENT SAMPLE WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).