FDA.reportPublic FDA data

MAUDE MDR 7762047

MDR report key
7762047
Report number
1823260-2018-02641
Event key
0
Event type
3
Date of event
2018-07-16
Date received
2018-08-08
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#

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
1VANCOMYCINRADIOIMMUNOASSAY, VANCOMYCINROCHE DIAGNOSTICSLEHNAASKU290451R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-080

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR VANC3 VANCOMYCIN ON A COBAS 6000 C (501) MODULE - C501. THE PATIENT DID NOT HAVE ANY KNOWN GAMMOPATHY. THE SAMPLE INITIALLY RESULTED WITH A VANC3 VALUE OF 124.1 UG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:3 AND REPEATED, RESULTING WITH A RAW VALUE OF 32.6 UG/ML WHICH CALCULATED TO A FINAL VALUE OF 97.8 UG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS ALSO DILUTED 1:3 AND REPEATED A SECOND TIME, RESULTING WITH A RAW VALUE OF 30.9 UG/ML WHICH CALCULATED TO A FINAL VALUE OF 92.7 UG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE 92.7 UG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE BIOLOGIST WAS SURPRISED BY THE HIGH VALUE AS THE PATIENT'S VANCOMYCIN MEDICATION (2500 MG.) WAS STOPPED ON (B)(6) 2018. HE ASKED FOR THE SAMPLE TO BE REPEATED AT A SECOND LABORATORY. THE SAMPLE WAS REPEATED AT THE SECOND LABORATORY ON A SIEMENS DIMENSION ANALYZER ON (B)(6) 2018, RESULTING AS 0.9 MG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE C501 ANALYZER SERIAL NUMBER WAS (B)(6). ALL LEVELS OF QUALITY CONTROLS WERE WITHIN RANGE FOR THE MONTH OF JULY. CALIBRATION SIGNALS FOR THE LAST CALIBRATION PERFORMED ON (B)(6) 2018 WERE CONSISTENT. A GENERAL ISSUE WITH THE REAGENT AND INSTRUMENT COULD BE EXCLUDED AS CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE.