FDA.reportPublic FDA data

MAUDE MDR 6677236

MDR report key
6677236
Report number
1823260-2017-01370
Event key
0
Event type
3
Date of event
2017-06-15
Date received
2017-06-29
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 DIAGNOSTICSDCNC50104745914001NAR Y
1COBAS 6000 C (501) MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEC50104745914001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-290

Event Narratives#

N

Patient 1

UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER OBTAINED A QUESTIONABLE LOW TEST RESULT FOR ONE PATIENT SAMPLE USING THE CRPL3 C-REACTIVE PROTEIN GEN.3 (CRPL3) ASSAY ON THE COBAS 6000 C (501) MODULE. ALL RESULTS ARE IN UNITS OF MG/L, AND ALL WERE RELEASED OUTSIDE OF THE LABORATORY. THE INITIAL CRPL3 RESULT WAS 1. THIS RESULT WAS AUTOMATICALLY SENT TO THE PHYSICIANS. THE CUSTOMER NOTICED THAT THE RESULTS FOR OTHER TESTS FOR THIS PATIENT HAD UNSPECIFIED ALARMS, SO THE CUSTOMER REPEATED THE SAMPLE. THE CRPL3 RESULT WAS 334.7. NO OTHER RESULT DATA WAS PROVIDED. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CRPL3 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. INVESTIGATION ACTIVITIES ARE ONGOING.

N

Patient 1

QUALITY CONTROL AND PRECISION TESTING INFORMATION WERE ACCEPTABLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE FOR THE NON-REPRODUCIBLE LOW DISCREPANT RESULT WAS A PARTIALLY BLOCKED SAMPLE PROBE.