FDA.reportPublic FDA data

MAUDE MDR 7215020

MDR report key
7215020
Report number
1823260-2018-00207
Event key
0
Event type
3
Date of event
2018-01-03
Date received
2018-01-24
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 C (501) MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCEMC50104745914001NAR Y
1COBAS 6000 C (501) MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEC50104745914001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-240

Event Narratives#

N

Patient 1

(B)(4)

D

Patient 1

THE CUSTOMER STATED THAT FROM APPROXIMATELY (B)(6) 2017 TO (B)(6) 2018, THEY HAVE SEEN A SHIFT IN QUALITY CONTROL AND PATIENT RESULTS FOR ISE INDIRECT K FOR GEN.2 (POTASSIUM) ON THE COBAS 6000 C (501) MODULE - C501. SODIUM AND CHLORIDE ISE TESTS WERE FINE. ON (B)(6) 2017, A DOCTOR QUESTIONED HIGH POTASSIUM RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. THE CUSTOMER PULLED THESE SAMPLES AND REPEATED THEM. REPEAT RESULTS FOR THESE SAMPLES WERE LOWER THAN THE INITIAL RESULTS. THE CUSTOMER THEN REPEATED ALL SAMPLES THAT WERE TESTED THAT DAY AND CORRECTED REPORTS FOR MULTIPLE PATIENT SAMPLES. RESULTS FROM THE CUSTOMER SITE WERE ALSO CONSISTENTLY HIGH COMPARED TO RESULTS OBTAINED AT A SISTER FACILITY. THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 9 PATIENT SAMPLES THAT HAD ERRONEOUS INITIAL RESULTS WHICH WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS FROM THESE SAMPLES WERE BELIEVED TO BE CORRECT. THE FIRST SAMPLE INITIALLY RESULTED AS 5.32 MMOL/L AND REPEATED AS 4.58 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED AS 5.6 MMOL/L AND REPEATED AS 4.8 MMOL/L. THE THIRD SAMPLE INITIALLY RESULTED AS 5.2 MMOL/L AND REPEATED AS 4.5 MMOL/L. THE FOURTH SAMPLE INITIALLY RESULTED AS 4.6 MMOL/L AND REPEATED AS 3.9 MMOL/L. THE FIFTH SAMPLE INITIALLY RESULTED AS 4.7 MMOL/L AND REPEATED AS 4.1 MMOL/L. THE SIXTH SAMPLE INITIALLY RESULTED AS 4.9 MMOL/L AND REPEATED AS 4.2 MMOL/L. THE SEVENTH SAMPLE INITIALLY RESULTED AS 5.0 MMOL/L AND REPEATED AS 4.4 MMOL/L. THE EIGHTH SAMPLE INITIALLY RESULTED AS 5.1 MMOL/L AND REPEATED AS 4.5 MMOL/L. THE NINTH SAMPLE INITIALLY RESULTED AS 5.1 MMOL/L AND REPEATED AS 4.4 MMOL/L. NO PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. NO PATIENTS WERE ADVERSELY AFFECTED. THE LOT NUMBER AND EXPIRATION DATE OF THE POTASSIUM ELECTRODE WAS ASKED FOR, BUT NOT PROVIDED. THE CUSTOMER CHECKED THE INSTRUMENT AND DID NOT FIND ANYTHING OBVIOUSLY WRONG, EXCEPT THAT IT SEEMED LIKE THERE WAS A LARGER AMOUNT OF SALT BUILDUP ON THE ISE CONCENTRATED WASTE NIPPLE. THE CUSTOMER STARTED RUNNING CONTROLS EVERY TWO HOURS AND STARTED MONITORING THEIR RESULTS USING DELTA CHECKS. THE FIELD SERVICE ENGINEER FOUND THAT THERE WAS SALT BUILDUP ON THE REFERENCE ELECTRODE. HE PERFORMED CLEANING OF THE ISE CHAMBER. HE PERFORMED A SUCCESSFUL ISE CHECK, QUALITY CONTROLS, AND PRECISION STUDIES.

N

Patient 1

THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.