FDA.reportPublic FDA data

MAUDE MDR 5799774

MDR report key
5799774
Report number
1219913-2016-00126
Event key
0
Event type
3
Date of event
2016-06-19
Date received
2016-07-15
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. STEPHEN PERRY
Address
333 CONEY STREET EAST WALPOLE MA 02032 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVIA CENTAUR XP PROGESTERONE (PRGE)PROGESTERONE IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.JLSN/A10310305273N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-150

Event Narratives#

N

Patient 1

THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS BETWEEN THE TWO PATIENT SAMPLES, AND THE HIGHER RESULT COMPARED TO THE ALTERNATE LABORATORY AND PROGESTERONE TEST METHOD IS UNKNOWN. SIEMENS IS INVESTIGATING.

D

Patient 1

DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS WERE OBSERVED BY THE CUSTOMER WHEN COMPARING TWO SAMPLES DRAWN FROM THE SAME PATIENT WITHIN A FEW HOURS OF ONE ANOTHER. THE FIRST SAMPLE (B)(6) WAS DRAWN AT THE (B)(6) BRANCH AND THE RESULT OBTAINED ON THE ADVIA CENTAUR XP AND IMMULITE 2000 XPI INSTRUMENTS DID NOT MATCH. THE INITIAL RESULT FROM THE ADVIA CENTAUR XP WAS REPORTED TO THE PHYSICIANS. A SECOND SAMPLE WAS DRAWN FROM THE PATIENT A FEW HOURS LATER AT THIS CUSTOMER SITE, TESTING ON THE IMMULITE 2000 XPI AND ADVIA CENTAUR XP AND THE RESULTS DID NOT MATCH. THE CUSTOMER IS ALSO QUESTIONING DIFFERENCE OF THE FIRST AND SECOND SAMPLE RESULTS. IT IS UNKNOWN WHICH RESULTS WERE CONSIDER CORRECT. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP PROGESTERONE ASSAY RESULTS.

N

Patient 1

SIEMENS FILED THE INITIAL MDR 1219913-2016-00126 ON 07/15/2016 FOR DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS FOR TWO SAMPLES DRAWN FROM THE SAME PATIENT, AND FOR ELEVATED RESULTS COMPARED TO THE IMMULITE 2000 XP1. ON 07/25/2016 ADDITIONAL INFORMATION: THE IMMULITE 2000 XPI REAGENT LOT NUMBER WAS 457 AT THE TIME OF THE INCIDENT. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS FROM TWO SAMPLES DRAWN FROM THE SAME PATIENT IS UNKNOWN. THE PATIENT SAMPLES, MEDICATIONS OR TREATMENT WERE NOT PROVIDED FOR FURTHER INVESTIGATION OR TO RULE OUT CROSS REACTIVITY. THE CONTROLS WERE IN RANGE AT THE TIME OF THE INCIDENT INDICATING THAT THE ASSAY IS PERFORMING AS EXPECTED. THE ADVIA CENTAUR XP USES MOUSE MONOCLONAL, AND IMMULITE 2000 XPI USES RABBIT POLYCLONAL ANTIBODIES, THEREFORE THEY CAN SHOW DIFFERENT CROSS REACTIVITY. IMMUNOASSAYS CAN BE SUBJECT TO A NUMBER OF INTERFERENCES INCLUDING EXOGENOUS INTERFERENCES SUCH AS DRUGS, NUTRITIONAL SUPPLEMENTS AND/OR HERBAL MEDICINE IN THE BLOOD. THE ADVIA CENTAUR XP PROGESTERONE INSTRUCTIONS FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

N

Patient 1

SIEMENS FILED THE INITIAL MDR 1219913-2016-00126 ON 07/15/2016 FOR DISCORDANT ADVIA CENTAUR XP PROGESTERONE (PRGE) RESULTS FOR TWO SAMPLES DRAWN FROM THE SAME PATIENT, AND FOR ELEVATED RESULTS COMPARED TO THE IMMULITE 2000 XP1. MDR 1219913-2016-00126 SUPPLEMENTAL REPORT 1 WAS FILED ON 08/05/2106 FOR ADDITIONAL INVESTIGATION INFORMATION. ON 08/18/2016: THE CATALOG # 10310505 STATED IN THE MDR INITIAL REPORT WAS A TYPOGRAPHICAL ERROR. THE CORRECT CATALOG # IS 10310305. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.