FDA.reportPublic FDA data

MAUDE MDR 7142245

MDR report key
7142245
Report number
MW5074195
Event key
0
Event type
3
Date received
2017-12-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROCHEMPA (MYCOPHENOLIC ACID ASSAY)ROCHEDLJMPAI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-2101. O

Event Narratives#

D

Patient 1

BEGINNING IN (B)(6) 2017 THROUGH (B)(6) 2017, THERE WERE 5 INSTANCES WHERE A SET OF 5 SAMPLES APPEARED TO BE MISSING, BUT WERE FOUND ON THE ROCHE MPA. IN WORKING WITH THE VENDOR IT WAS EVENTUALLY DETERMINED THAT SINCE THE LAB HAS 2 MPA INSTRUMENTS THAT RACKS FROM MPA 1 WERE BEING USED ON MPA2. THESE RACKS ARE IDENTICAL INCLUDING THE BAR CODE NUMBERS WITH THE EXCEPTION OF A GREEN STICKER FOR MPA. WHEN THE SECOND RACK WITH THE SAME BAR CODE NUMBER IS INTRODUCED TO THE ANALYZER AND THE FIRST RACK WITH THE SAME NUMBER IS CURRENTLY BEING PROCESSED, THE ANALYZER WILL PRODUCE AN ERROR MESSAGE THAT INDICATES "RACK AND POS IS ALREADY OCCUPIED BY ANOTHER SAMPLE." THE INSTRUMENT ALLOWS THE OPERATOR TO OVERRIDE THE ERROR AND RE-INTRODUCE THE RACK. THE INSTRUMENT THAN DISASSOCIATES THE FIRST SET OF PT DEMOGRAPHICS AND REPLACES IT WITH THE SECOND SET OF PT DEMOGRAPHICS, THEREBY TESTING THE 1ST SET OF SAMPLES AND APPLYING THE SECOND SET OF PT DEMOGRAPHICS TO THE RESULT. THIS CAUSE 22 RESULTS TO BE REPORTED ON THE INCORRECT PTS.