FDA.reportPublic FDA data

MAUDE MDR 6061132

MDR report key
6061132
Report number
1823260-2016-01649
Event key
0
Event type
3
Date of event
2016-10-09
Date received
2016-10-27
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
1NH3L AMMONIAENZYMATIC METHOD, AMMONIAROCHE DIAGNOSTICSJIFNA2076668232215816001R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-270

Event Narratives#

N

Patient 1

(B)(4)

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FIVE SAMPLES FROM THE SAME PATIENT TESTED FOR NH3L AMMONIA (NH3) ON A C501 ANALYZER. THE RESULTS FROM ALL 5 SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY AND SENT BACK BY THE DOCTOR DUE TO NOT MATCHING THE PATIENT'S CLINICAL CONDITION. (B)(6). THE PATIENT WAS NOT ADVERSELY AFFECTED. THE C501 ANALYZER SERIAL NUMBER WAS (B)(4). WHEN THE CUSTOMER WAS ASKED ABOUT REAGENT HANDLING, IT WAS CONFIRMED THAT THE CUSTOMER DID NOT UNSCREW A REAGENT BOTTLE CAP AND LEAVE THE REAGENT CASSETTE IN A DARK, COVERED PLACE FOR 24 HOURS PRIOR TO PLACING IT ON THE INSTRUMENT AS INSTRUCTED IN THE PACKAGE INSERT. THE CUSTOMER WAS INFORMED THAT NOT DOING THIS WOULD RESULT IN HIGH AMMONIA RECOVERY. THE CUSTOMER WAS INFORMED THAT THE CURRENT REAGENT PACK SHOULD NOT BE USED AND THAT A NEW REAGENT CASSETTE SHOULD BE PREPARED FOR USE ACCORDING TO THE PACKAGE INSERT. THE CUSTOMER PREPARED A NEW CASSETTE AS INSTRUCTED. CALIBRATION AND CONTROLS WERE ACCEPTABLE WITH THE NEW CASSETTE. CONTROLS HAD A SLIGHT DECREASE IN RECOVERY FOR THE NEW CASSETTE VERSUS CONTROL RECOVERY FOR THE OLD CASSETTE THAT HAD NOT BEEN PREPARED PROPERLY. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE. HE CHECKED PROBE ADJUSTMENTS, WASH PRESSURES, THE RINSE MECHANISM, AND DRY POSITIONS. EVERYTHING WAS FOUND TO BE OK. THE CUSTOMER RAN CALIBRATION AND CONTROLS; THE RESULTS WERE OK. THE CUSTOMER RAN A PRECISION STUDY AND THIS WAS OK.

N

Patient 1

THE FIELD SERVICE ENGINEER CHECKED SPECIAL WASH PROGRAMMING AND THIS WAS GOOD. THE CUSTOMER HAS NOT EXPERIENCED ANY FURTHER ISSUES SINCE CORRECTLY HANDLING REAGENT CASSETTES. INVESTIGATIONS HAVE DETERMINED THAT THE ISSUE WAS SOLVED BY CORRECT HANDLING OF THE REAGENT CASSETTE. THE PRODUCT WAS FOUND TO MEET SPECIFICATIONS.