FDA.reportPublic FDA data

MAUDE MDR 3574956

MDR report key
3574956
Report number
2432235-2014-00126
Event key
0
Event type
3
Date of event
2013-09-19
Date received
2014-01-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. ELIZABETH BEATO
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
1IMMULITE 2000 ANDROSTENEDIONEIMMULITE 2000 ANDROSTENEDIONESIEMENS HEALTHCARE DIAGNOSTICS INC.CIZIMMULITE 2000 ANDROSTENEDIONEL2KAO314, 316N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-140

Event Narratives#

D

Patient 1

THE CUSTOMER HAS OBSERVED HIGH BIAS ON BIORAD QUALITY CONTROL SAMPLE LEVEL 2 AND PATIENT SAMPLES FOR THE ANDROSTENEDIONE ASSAY ON AN IMMULITE 2000 INSTRUMENT WHEN USING REAGENT LOT 314 AND 316. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS OBSERVED ON BIORAD QUALITY CONTROL SAMPLE LEVEL 2 AND PATIENT SAMPLES WHEN USING REAGENT LOT 314 AND 316.

N

Patient 1

SIEMENS HAS INVESTIGATED THE INCIDENCE OF OVER RECOVERY OF PATIENT SAMPLES AND QUALITY CONTROLS ON THE IMMULITE/IMMULITE1000 ANDROSTENEDIONE ASSAY LOT NUMBER 409 AND ABOVE, AND IMMULITE 2000/IMMULITE 2000 XPI ANDROSTENEDIONE ASSAY LOT NUMBER 314 AND ABOVE. SIEMENS HAS CONFIRMED THAT THESE LOTS ARE LINEAR UP TO A CONCENTRATION OF 5.5 NG/ML, INSTEAD OF THE 10 NG/ML AS STATED IN THE INSTRUCTIONS FOR USE (IFU). QUALITY CONTROL MATERIALS AT CONCENTRATIONS BETWEEN 5.5 NG/ML AND 10 NG/ML WILL DETECT THIS ISSUE. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) 2013-12-19 WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 4008 WAS SENT TO OUS CUSTOMERS IN DECEMBER OF 2013. THE UMDC AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO USE QUALITY CONTROL MATERIALS WITH AT LEAST TWO LEVELS HAVING CONCENTRATIONS LESS THAN 5.5 NG/ML, AND THAT PATIENT VALUES >5.5 NG/ML SHOULD BE VERIFIED USING AN ALTERNATE METHOD.

N

Patient 1

THE ORIGINAL MDR 2432235-2014-00126 WAS FILED ON JANUARY 14, 2014. ADDITIONAL INFORMATION (5/27/14): THE OVER RECOVERY AND LOSS OF LINEARITY OF THE IMMULITE SYSTEMS ANDROSTENEDIONE ASSAY HAS BEEN IDENTIFIED TO BE VARIABILITY OF A CRITICAL RAW MATERIAL (VARIATION IN THE ACTIVITY OF RMA160 ALKALINE PHOSPHATASE (UNLABELED/LOW ACTIVITY ALKALINE PHOSPHATASE, COLD AP) IN THE REAGENT WEDGE). IN ADDITION, SIEMENS HEALTHCARE SENT OUT A CUSTOMER BULLETIN 2014-05 IN MAY 2014, ANNOUNCING THE RESTORATION OF THE LINEARITY OF THE ANDROSTENEDIONE ASSAY ON THE IMMULITE 2000/IMMULITE 2000 XPI TO 10 NG/ML (35 NML/L), BEGINNING WITH KIT LOT 331.