MAUDE MDR 5887379

MDR report key
5887379
Report number
2432235-2016-00489
Event key
0
Event type
3
Date of event
2016-07-24
Date received
2016-08-18
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
TIMOTHY RICE
Address
511 BENEDICT AVE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0ADVIA CENTAUR XPCLINICAL CHEMISTRY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.JMGADVIA CENTAUR XPN N
1ADVIA CENTAUR XPCLINICAL CHEMISTRY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.JJEADVIA CENTAUR XPN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-180

Event Narratives#

N

Patient 1

A CUSTOMER CALLED IN TO A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST STATING THEY ARE EXPERIENCING FAILING CALIBRATIONS DUE TO HIGH COEFFICIENT OF VARIATION (CV) AND INTERMITTENT SIGNAL ERRORS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE PERFORMED A TOTAL SERVICE CALL. THE CSE FOUND THAT THE ACID PUMP WAS LEAKING AND REPLACED THE ACID PUMP. THE CSE FOUND ASPIRATE PROBE 3 AND REAGENT PROBE 3 WERE BENT AND REPLACED BOTH PROBES. THE CSE FOUND A LOOSE PROBE 1 WASH BOWL AND TIGHTENED IT. THE CSE REPAIRED 2 PINCH VALVES. THE CSE THEN RECALIBRATED AND RAN FRESH QUALITY CONTROL (QC), WHICH PASSED. THE CAUSE OF THE DISCORDANT, FALSELY DEPRESSED FERRITIN RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

A DISCORDANT, FALSELY DEPRESSED FERRITIN (FER) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED OUT TO THE PHYSICIAN(S). A SECOND SAMPLE WAS TESTED ON THE SAME ADVIA CENTAUR XP INSTRUMENT, RESULTING ABOVE THE ASSAY RANGE. THE CUSTOMER DILUTED THE SAMPLE (1:10) AND REPEATED THE TEST, RESULTING HIGHER THAN ORIGINAL SAMPLE AND MATCHING THE PATIENTS CLINICAL HISTORY. THE REPEAT RESULT WAS REPORTED OUT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED FERRITIN RESULT.