FDA.reportPublic FDA data

MAUDE MDR 3652198

MDR report key
3652198
Report number
9612296-2014-00039
Event key
0
Event type
3
Date of event
2014-02-05
Date received
2014-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. DUNG NGUYEN
Address
250 S. KRAEMER BOULEVARD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZERANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USEBECKMAN COULTERMZVAU681-10EB12188NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-270

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED GENERATING HIGH POTASSIUM (K) RESULTS FROM THE BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH K RESULTS FOR THREE (3) PATIENTS. THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH K RESULTS FOR THREE (3) PATIENTS, BUT PROVIDED ONLY ONE VERBAL EXAMPLE OF A K RESULT OF 8 MMOL/L WHICH RECOVERED A RESULT OF 4 MMOL/L UPON REPEAT. NO ERRONEOUS RESULTS WERE GENERATED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY INSTRUMENT PRINTOUTS OR PATIENT DEMOGRAPHICS INFORMATION FOR THIS EVENT.

N

Patient 1

(B)(6). A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE. THE CTS ADVISED THE CUSTOMER TO REPLACE THE SAMPLE PROBE AND POTASSIUM (K) ELECTRODE TO RESOLVE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS THEN DISPATCHED TO THE CUSTOMER'S SITE. THE FSE VERIFIED THE REPAIRS PERFORMED BY THE CUSTOMER BY CARRYING OUT A PRECISION RUN, AND CHECKING THE CALIBRATION SLOPES WHICH PASSED PUBLISHED SPECIFICATIONS. IN CONCLUSION, THE MOST LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO A K ELECTRODE MALFUNCTION. THE K ELECTRODE WAS REPLACED BY THE CUSTOMER AND THE CUSTOMER HAS NOT REPORTED OF ANY FURTHER ISSUES RELATED TO THIS INCIDENT.