FDA.reportPublic FDA data

MAUDE MDR 6838417

MDR report key
6838417
Report number
2432235-2017-00505
Event key
0
Event type
3
Date of event
2017-06-21
Date received
2017-09-01
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
AARTI AZIZ
Address
511 BENEDICT AVENUE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2)ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2)SIEMENS HEALTHCARE DIAGNOSTICS INC.CFNADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_210309032411515N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-010

Event Narratives#

N

Patient 1

A SIEMENS REGIONAL APPLICATION SPECIALIST (RAS) REVIEWED THE REACTION CURVES AND DATA PROVIDED BY THE CUSTOMER AND DETERMINED THAT THE FALSELY LOW IGM_2 RESULTS MAY HAVE BEEN PRODUCED BY SOME INHIBITORY AGENT PRESENT WITHIN THE SAMPLE. THE MANUAL PRE-DILUTION OF THE SAMPLE REDUCES THE EFFECT OF THE INTERFERENCE AND ALLOWS THE TRUE ELEVATED VALUE TO BE MEASURED. THE ADVIA 2400 INSTRUMENT DID NOT GENERATE ANY ERRORS ON THE INITIAL RESULT BECAUSE THE REACTION CURVE SHOWS NO ABNORMALITIES. IT ALSO SHOWS THAT THERE WAS NO PROZONE OR HOOK EFFECT AND THAT THE FALSELY LOW IGM_2 RESULTS WERE NOT OBTAINED DIRECTLY DUE TO AN ANTIGEN EXCESS. THE RAS SPECIALIST CONCLUDED THAT THE POSSIBLE CAUSES OF THE DISCORDANT RESULTS COULD BE STERIC HINDRANCE BY HIGH PROTEIN CONCENTRATION OR NON-SPECIFIC BINDING OF ANTIBODIES IN IGM_2 REAGENT TO SOME SPECIFIC AGENT PRESENT IN THE SAMPLE OR SOME OTHER PARA-PROTEIN SUCH AS PRESENCE OF HUMAN ANTI-GOAT ANTIBODIES. THE ADVIA 2400 IGM_2 METHOD USES GOAT ANTI-HUMAN IGM ANTIBODIES. IF THE PATIENT HAS BEEN EXPOSED TO GOATS THEY MAY HAVE ANTI-GOAT ANTIBODIES PRESENT IN THEIR BLOOD. IF THIS IS THE CAUSE, OTHER IGM_2 RESULTS ON THE ADVIA 2400 INSTRUMENT MAY ALSO BE FALSELY LOW. A REGIONAL SUPPORT CENTER SPECIALIST STATED THAT THE QUALITY CONTROLS AND OTHER PATIENT SAMPLES FOR IGM_2 HAVE BEEN RECOVERING REPRODUCIBLY. THEREFORE, THIS SAMPLE APPEARS TO BE AN ISOLATED INCIDENT. A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED THE EVENT DATA AND CONCLUDED THAT THIS IS NOT A METHOD OR REAGENT LOT ISSUE. THE SYSTEM IS FUNCTIONING AS DESIGNED. QUALITY CONTROL WAS WITHIN ACCEPTABLE RANGE AND ONLY ONE SAMPLE WAS IMPACTED. THIS DATA IS CONSISTENT WITH INTERFERENCE, HOWEVER, THE INTERFERENCE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. AS PER ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 (IGM_2) INSTRUCTIONS FOR USE STATE, A NUMBER OF SUBSTANCES CAUSE PHYSIOLOGICAL CHANGES IN SERUM ANALYTE CONCENTRATIONS. AS WITH ANY CHEMICAL REACTION, THE CUSTOMER MUST BE ALERT TO THE POSSIBLE EFFECT ON RESULTS OF UNKNOWN INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES. THE LABORATORY AND PHYSICIAN MUST EVALUATE ALL PATIENT RESULTS IN LIGHT OF THE TOTAL CLINICAL STATUS OF THE PATIENT. THE SYSTEM AND ASSAY IS WORKING AS SPECIFIED. THE CAUSE OF THE DISCORDANT, FALSELY LOW IGM_2 RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED. MDR 2432235-2017-00432 WAS FILED FOR THE SAME EVENT.

D

Patient 1

ON (B)(6) 2017, A DISCORDANT, FALSELY LOW IMMUNOGLOBULIN M_2 (IGM_2) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE WHEN RUN NEAT ON AN ADVIA 2400 INSTRUMENT, WHILE USING REAGENT LOT 411515. ON (B)(6) 2017, THE SAMPLE WAS ANALYZED USING AN ALTERNATE METHODOLOGY, RESULTING HIGH AND INDICATIVE OF HIGH PARAPROTEIN BAND. THE CUSTOMER CONFIRMED THE HIGH RESULT BY REPEATING THE SAMPLE ON THE ALTERNATE METHODOLOGY. THIS PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE AS NEAT AND WITH DILUTION ON THE ADVIA 2400 INSTRUMENT. THIS IS WHEN THE CUSTOMER DETERMINED THAT THE NEAT RESULTS AND A RESULT OBTAINED UPON INITIAL DILUTION ON THE ADVIA 2400 INSTRUMENT WERE DISCORDANT. THE RESULTS FROM THE ELECTROPHORESIS AND THE RESULTS OBTAINED ON THE ADVIA 2400 INSTRUMENT UPON MANUAL DILUTION WERE CONSIDERED CORRECT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IGM_2 RESULTS.