FDA.reportPublic FDA data

MAUDE MDR 6696399

MDR report key
6696399
Report number
1823260-2017-01414
Event key
0
Event type
3
Date of event
2017-06-20
Date received
2017-07-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0COBAS 6000 C (501) MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCJWC50104745914001NAR Y
1COBAS 6000 C (501) MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEC50104745914001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-100

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

D

Patient 1

THE CUSTOMER STATED THAT BETWEEN (B)(6) 2017, THEY HAD ISSUES WITH QUALITY CONTROLS RANDOMLY BEING OUTSIDE OF RANGE FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (MALB) ON THE COBAS 6000 C (501) MODULE - C501. THE CONTROLS WERE REPEATED AND THEN RECOVERED OKAY. ON (B)(6) 2017, THE CUSTOMER NOTICED THAT THEY ALSO WERE HAVING ISSUES WITH DISCREPANT PATIENT RESULTS. THE CUSTOMER STARTED TO REPEAT ALL PATIENT SAMPLES TO ENSURE THE INSTRUMENT WAS GENERATING CORRECT RESULTS THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 13 SAMPLES THAT HAD QUESTIONABLE MALB RESULT. OF THESE, THREE HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED AS 28.5 MG/L. THE SAMPLE WAS REPEATED TWICE, RESULTING AS 11.3 MG/L AND 8.0 MG/L. THE SECOND SAMPLE INITIALLY RESULTED AS 25.3 MG/L. THE SAMPLE WAS REPEATED TWICE, RESULTING AS 6.3 MG/L AND < 3 MG/L. THE THIRD SAMPLE INITIALLY RESULTED AS 107.9 MG/L ON (B)(6) 2017. THE SAMPLE WAS REPEATED TWICE, RESULTING AS 24.4 MG/L AND 30.4 MG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE MALB REAGENT LOT NUMBER WAS 219743. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. PRECISION STUDIES WERE PERFORMED ON THE ANALYZER AND PRECISION FOR TRIGLYCERIDES WAS OUTSIDE OF SPECIFICATIONS. THE FIELD SERVICE ENGINEER FOUND THAT THERE WAS AN ISSUE WITH THE CUSTOMER'S WATER SYSTEM. THE CARBON LEVELS OF THE WATER WERE HIGH.