FDA.reportPublic FDA data

MAUDE MDR 6757468

MDR report key
6757468
Report number
1823260-2017-01577
Event key
0
Event type
3
Date of event
2017-07-12
Date received
2017-08-01
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
105
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 C501 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSLBSC50105860636001NAR Y
1COBAS 6000 C501 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEC50105860636001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-010

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDL) ON A COBAS 6000 C (501) MODULE - C501. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT OTHER PATIENT SAMPLES RESULTED NORMALLY. THE CUSTOMER BELIEVED THE ISSUE TO BE RELATED TO THE INSTRUMENT AS IT HAD HAPPENED BEFORE IN THE PAST. NO FURTHER DETAILS WERE PROVIDED REGARDING THIS PREVIOUS EVENT. THE SAMPLE INITIALLY RESULTED AS 113 MG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER, RESULTING AS 43 MG/DL. NO TREATMENT WAS PROVIDED TO THE PATIENT SINCE NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HDL REAGENT LOT NUMBER WAS 200767, WITH AN EXPIRATION DATE OF 07/31/2018. THE REAGENT HAD BEEN IN USE ON THE ANALYZER SINCE (B)(6) 2017. THE FIELD SERVICE ENGINEER FOUND CONTAMINATION IN THE INSTRUMENT. HE PERFORMED A DECONTAMINATION OF THE INSTRUMENT. HE CLEANED THE CIRCULATION PATHS, INCLUDING THE AIR TRAP AND LAMP HOLDER. HE REPLACED A VALVE. HE RAN PHOTOMETRIC TESTS AND THESE PASSED. THE CUSTOMER RAN QUALITY CONTROLS AND THESE WERE WITHIN LABORATORY SPECIFICATIONS. PRECISION STUDIES WERE PERFORMED AND THESE WERE WITHIN SPECIFICATION. THE CUSTOMER ALSO NOTED THAT THE ENGINEER CLEANED THE INCUBATOR BATH AND INFORMED THE CUSTOMER THAT THERE COULD POTENTIALLY BE AN ISSUE WITH THE MIXING STATION. PARTS WERE ORDERED TO REPLACE THE MIXING STATION.