FDA.reportPublic FDA data

MAUDE MDR 4059640

MDR report key
4059640
Report number
2517506-2014-00182
Event key
0
Event type
3
Date of event
2014-07-30
Date received
2014-09-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JAMES MORGERA
Address
GLASGOW BUSINESS COMMUNITY 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? CLINICAL CHEMISTRY SYSTEMMASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGESIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOWJHYRF420ED5167N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-040

Event Narratives#

D

Patient 1

A CUSTOMER OBSERVED BIASED LOW MASS CREATININE KINASE MB ISOENZYME (MMB) RESULTS ON PATIENT CROSSOVER AND QC SAMPLES ON LOT ED5167 REAGENT CARTRIDGES. NO PATIENT RESULTS WERE REPORTED TO PHYSICIANS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE BIASED LOW MMB RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BIASED LOW MMB RESULTS.

N

Patient 1

THE CAUSE OF THE BIASED LOW MASS CREATININE KINASE MB ISOENZYME (MMB) RESULTS IS LOT TO LOT VARIABILITY OF THE MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE. THE ISSUE WAS RESOLVED BY THE CUSTOMER WITH THE USE OF AN ALTERNATE LOT WHICH PROVIDED BETTER CORRELATION TO THE CUSTOMER'S PRIOR MMB LOT. SIEMENS HEALTHCARE TECHNICAL SERVICE LABORATORY CONDUCTED AN INVESTIGATION OF LOT ED5167 AND DID NOT CONFIRM THE CUSTOMER'S COMPLAINT FOR LOT TO LOT VARIABILITY. NO FURTHER INVESTIGATION IS REQUIRED.