FDA.reportPublic FDA data

MAUDE MDR 6446569

MDR report key
6446569
Report number
2517506-2017-00297
Event key
0
Event type
3
Date of event
2017-03-15
Date received
2017-03-30
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
JAMES MORGERA
Address
GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US
Phone
302-302-3026
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIMENSION?DIMENSION? MMB MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGESIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOWJHYRF420 SMN 10444904BA7286N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-300

Event Narratives#

N

Patient 1

ANALYSIS OF THE INFORMATION PROVIDED INDICATES THAT THE CAUSE FOR THE DISCORDANT ELEVATED MMB RESULT IS UNKNOWN. A SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER REPRESENTATIVE EVALUATED THE INFORMATION PROVIDED AND CONCLUDED THAT THE ELEVATED MMB VALUE WAS REPEATABLE AND DISCORDANT WITH OTHER CARDIAC TEST VALUES. THE DISCORDANT ELEVATED VALUE WAS OBTAINED IN THE ABSENCE OF INSTRUMENT ISSUES AND WHILE QC WAS WITHIN RANGE. THE INSTRUCTIONS FOR USE FOR THE MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. NEVERTHELESS, COMPLETE ELIMINATION OF THIS INTERFERENCE CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION." THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

A DISCORDANT ELEVATED MASS CREATINE KINASE MB ISOENZYME (MMB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL 200 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RETESTED ON AN ALTERNATE NON-SIEMENS ANALYZER AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED MMB RESULT.