FDA.reportPublic FDA data

MAUDE MDR 6885792

MDR report key
6885792
Report number
1823260-2017-02043
Event key
0
Event type
3
Date of event
2017-08-28
Date received
2017-09-22
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
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 DIAGNOSTICSCFRC50104745914001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-220

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). (B)(4).

D

Patient 1

THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR GLUC3 GLUCOSE HK (GLUC3) ON A COBAS 6000 C (501) MODULE. THE INITIAL GLUC3 RESULT WAS 153.6 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR QUESTIONED IT. ON (B)(6) 2017 THE SAMPLE WAS REPEATED AND THE RESULT WAS 113 .4 MG/DL. ON (B)(6) 2017 THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 108.0 MG/DL. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE GLUC3 REAGENT LOT NUMBER WAS 254446 WITH AN EXPIRATION DATE OF 30-SEP-2018. CALIBRATION AND QUALITY CONTROLS (QC) WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF ALARM TRACE DATA. BASED ON THE REACTION MONITOR PROVIDED, THE INITIAL HIGH RESULT SHOWED A GENERAL HIGHER ABSORBANCE. THE HIGH RESULT MAY HAVE BEEN DUE TO MORE SAMPLE PIPETTED INTO THE REACTION CELL. BASED ON THE PRECISION DATA PROVIDED, THERE MAY BE ISSUES WITH THE REAGENT PIPETTOR OR THE RINSE UNITS. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. SINCE CALIBRATION AND QC DATA WAS ACCEPTABLE, A GENERAL REAGENT ISSUE IS NOT SUSPECTED. BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE IS RELATED TO PRE-ANALYTICS OR DEPOSITS ON THE SAMPLE PROBE. TOO MUCH SAMPLE COULD HAVE BEEN TRANSFERRED DUE TO FIBRIN STRANDS WHICH CAN BE CAUSED BY IMPROPER PRIMARY TUBE HANDLING OR COAGULATION/CENTRIFUGATION ISSUES RELATED TO THE SAMPLE PROBE.