FDA.reportPublic FDA data

MAUDE MDR 6996012

MDR report key
6996012
Report number
1823260-2017-02508
Event key
0
Event type
3
Date of event
2017-10-16
Date received
2017-11-02
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 6000 C501 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCFRC50105860636001NAR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-020

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

HE CUSTOMER STATED THAT THEY HAD RECEIVED A DISCREPANT GLUC3 GLUCOSE HK RESULT FOR A PATIENT SAMPLE ON THE COBAS 6000 C (501) MODULE. THE INITIAL GLUCOSE RESULT WAS 47 MG/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER OBSERVED DATA FLAGS WITH OTHER RESULTS AND RERAN THE SAMPLE ON THE SAME C501 MODULE. THE REPEAT GLUCOSE RESULT WAS 91 MG/DL AND DEEMED TO BE CORRECT. THE CUSTOMER OBSERVED THE ISSUE AND CONTACTED THE PHYSICIAN IMMEDIATELY WITH THE CORRECT RESULT. NO PATIENT WAS AFFECTED. THE GLUCOSE REAGENT LOT NUMBER WAS 23629001 WITH AN EXPIRATION DATE OF 31-JULY-2018. AT THE SAME OCCURRENCE THE CUSTOMER RECEIVED TRIGL TRIGLYCERIDES RESULTS WITH DATA FLAGS FOR TWO PATIENT SAMPLES BUT DID NOT PROVIDE THE DATA. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENTS WERE NOT AFFECTED. THE SAMPLES WERE REPEATED WITH VALID RESULTS. THERE WERE NO ADVERSE EVENTS. THE FIELD SERVICE ENGINEER (FSE) COULD NOT DETERMINE A ROOT CAUSE. THE FSE PERFORMED A PRECISION CHECK THAT WAS "OKAY". THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROL WHICH RECOVERED AS EXPECTED. THE CUSTOMER RERAN 20 PATIENT SAMPLES AND ALL SAMPLES "MATCHED" THE INITIAL RESULT.