FDA.reportPublic FDA data

MAUDE MDR 6608266

MDR report key
6608266
Report number
1823260-2017-01134
Event key
0
Event type
3
Date of event
2017-05-09
Date received
2017-06-02
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 8000 C 702 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSLBSC70206473245001NAR Y
1COBAS 8000 C 702 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEC70206473245001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-020

Event Narratives#

N

Patient 1

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

D

Patient 1

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDLC3) ON A COBAS 8000 C 702 MODULE. THE INITIAL HDLC3 RESULT FROM THE PRIMARY TUBE WAS 0 MG/DL. THE SAMPLE WAS REPEATED THE SAME DAY FROM THE SAME PRIMARY TUBE USING A DIFFERENT REAGENT CASSETTE WITH THE SAME LOT NUMBER AND THE RESULT WAS 48 MG/DL. IT IS NOT CLEAR WHICH RESULT WAS CONSIDERED TO BE CORRECT OR IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HDLC3 REAGENT LOT NUMBER WAS 156809 WITH AN EXPIRATION DATE OF 03/31/2018. THE CUSTOMER?S CALIBRATION AND QUALITY CONTROLS (QC) RESULTS WERE COMPARABLE TO THOSE FROM OTHER DATES. NOTHING ABNORMAL WAS OBSERVED. MEASURING CELLS AND LAMPS WERE LAST REPLACED ON (B)(6) 2017. WEEKLY MAINTENANCE WAS LAST PERFORMED ON (B)(6) 2017. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED.

N

Patient 1

IT WAS CLARIFIED THAT THE RESULT OF 0 MG/DL WAS NOT BELIEVED TO BE CORRECT AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT OF 48 MG/DL WAS BELIEVED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. A FIELD SERVICE ENGINEER DECONTAMINATED AND ADJUSTED THE SAMPLE AND REAGENT PROBES. AFTER THESE ACTIONS, NO DISCREPANT RESULTS WERE OBSERVED.