FDA.reportPublic FDA data

MAUDE MDR 6753319

MDR report key
6753319
Report number
1823260-2017-01566
Event key
0
Event type
3
Date of event
2017-07-11
Date received
2017-07-31
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 E 601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSCDZE60104745922001NAR Y
1COBAS 6000 E 601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEE60104745922001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-310

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 THE ELECSYS TESTOSTERONE II ASSAY (TESTO) ON A COBAS 6000 E 601 MODULE (E601). THE SAMPLE (COLLECTED ON (B)(6) 2017) INITIALLY RESULTED AS 8.72 NG/DL AND THIS WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN ASKED FOR THE SAMPLE TO BE REPEATED. BEFORE REPEATING, THE SAMPLE WAS RE-CENTRIFUGED. THE SAMPLE WAS REPEATED ON A DIFFERENT E601 ANALYZER ON (B)(6) 2017, RESULTING AS 356.0 NG/DL. THE SAMPLE WAS ALSO REPEATED ON THE ORIGINAL E601 ANALYZER ON (B)(6) 2017, RESULTING AS 340.6 NG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENT WAS NOT PHYSICALLY HURT DURING THE EVENT AND DID NOT RECEIVE ANY CARE BASED ON THE ERRONEOUS RESULT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE TESTO REAGENT LOT NUMBER WAS 191053. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THAT THERE WAS AN ISSUE WITH A NOZZLE BOX ASSEMBLY. HE REPLACED THE ASSEMBLY. HE REPLACED THE SAMPLE PROBE AND CHECKED VOLTAGE. HE ADJUSTED THE MAIN PUMP AND GEAR PUMP PRESSURES TO SPECIFICATIONS. HE ADJUSTED THE RINSE STATIONS AND CHECKED THE EXTERNAL RINSE. HE ADJUSTED THE PROBES. HE RAN PERFORMANCE TESTING AND PRECISION STUDIES. PERFORMANCE TESTING PASSED WITHIN SPECIFICATIONS. ALL CONTROLS WERE ACCEPTABLE TO THE CUSTOMER. THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. THE FIELD SERVICE ENGINEER RAN PRECISION STUDIES USING THE SAME TUBES THAT WERE USED FOR PATIENT TESTING. THE VOLUME OF THE SAMPLE WAS APPROXIMATELY 2 ML AND THERE WAS A SMALL RED CELL BUTTON OBSERVED AT THE BOTTOM OF THE SAMPLE.