FDA.reportPublic FDA data

MAUDE MDR 6867909

MDR report key
6867909
Report number
1823260-2017-01992
Event key
0
Event type
3
Date of event
2017-08-26
Date received
2017-09-15
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
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 502 MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCHHC502ASKUNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-150

Event Narratives#

N

Patient 1

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

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR CHOL2 CHOLESTEROL GEN.2 (CHOL) ON A COBAS 8000 C 502 MODULE (C502). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 48.4 MG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER, RESULTING AS 208.1 MG/DL. THE CUSTOMER TRUSTED THE 208.1 MG/DL VALUE. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE CHOL REAGENT LOT NUMBER WAS 23624201, WITH AN EXPIRATION DATE OF 31-JAN-2018. QUALITY CONTROLS WERE WITHIN RANGE. THE LAST CALIBRATION WAS OK. UPON REVIEW OF THE ALARM TRACE, SEVERAL ABNORMAL SAMPLE ASPIRATION ALARMS COULD BE SEEN ON THE DAY OF THE EVENT. CENTRIFUGATION TIME OF THE SAMPLE APPEARED TO BE TOO LOW. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A GENERAL REAGENT PROBLEM COULD BE RULED OUT SINCE CALIBRATION AND CONTROL ARE ACCEPTABLE. IT CAN BE ASSUMED THAT A PRE-ANALYTICAL SAMPLE HANDLING ISSUE IS THE ROOT CAUSE OF THE EVENT.