FDA.reportPublic FDA data

MAUDE MDR 3393956

MDR report key
3393956
Report number
1823260-2013-06161
Event key
0
Event type
3
Date of event
2013-09-23
Date received
2013-10-08
Adverse event
3
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 JENNIFER WOLFGRAM
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
1AMMONIAENZYMATIC METHOD, AMMONIAROCHE DIAGNOSTICSJIFNA2076668232267213901R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-080

Event Narratives#

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR AMMONIA (NH3) ON ONE PATIENT SAMPLE. THE CUSTOMER CURRENTLY RUNS THE NH3 ASSAY ON THE COBAS 6000 C501 (C501) MODULE, AND WAS VALIDATING THE ASSAY ON THE MODULAR P (MODP) INSTRUMENT AT THE TIME OF THE EVENT. THE INITIAL NH3 RESULT FROM THE C501 WAS 285 UMOL/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN RUN ON THE MODP AND GENERATED A RESULT OF 66 UMOL/L. THE SAMPLE WAS REPEATED AGAIN ON THE MODP AND GENERATED A RESULT OF 121.9 UMOL/L. THE SAMPLE WAS THEN REPEATED ON THE C501 AND GENERATED A REPEAT RESULT OF 73.3 UMOL/L. THE CUSTOMER DEEMED THE RESULT OF 73.3 UMOL/L TO BE THE CORRECT RESULT AND ISSUED A CORRECTED REPORT. THERE WAS NO ADVERSE EVENT. THE LOT NUMBER OF NH3 REAGENT IN USE WAS 67213901, WITH AN EXPIRATION DATE OF 05/31/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE ULTRASONIC MIXER (USM) R3 NEEDED TO BE CHANGED. HE REPLACED THE USM R3, PERFORMED THE MIXING CHECK AND CLEANED THE OTHER USMS, WHICH HAD A BUILD UP WITHIN THEM. HE ALSO CHECKED THE TUBING AND RINSING OF THE RINSE MECHANISM, PROBES AND ALIGNMENTS ALONG WITH THE VACUUM AND WATER PRESSURES. HE PERFORMED A PRECISION AND ACCURACY CHECK, WITH ALL RESULTS WITHIN SPECIFICATION. HE ALSO PERFORMED A BLANK CALIBRATION AND THE QC WAS WITHIN THE CUSTOMER'S SPECIFICATION.

N

Patient 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

N

Patient 1

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE AMMONIA ASSAY IS SENSITIVE TO ENVIRONMENTAL INFLUENCES AND CAN BE IMMEDIATELY IMPACTED BY THE ENVIRONMENT. THIS IS DESCRIBED IN PRODUCT LABELING. BASED UPON INFORMATION PROVIDED, THE ISSUE APPEARS TO BE RELATED TO THE REAGENT PACK AND NOT THE MIXER ISSUES FOUND BY THE FIELD SERVICE REPRESENTATIVE. MIXER ISSUES WOULD HAVE IMPACTED ADDITIONAL ASSAYS.