FDA.reportPublic FDA data

MAUDE MDR 1833996

MDR report key
1833996
Report number
1823260-2010-05430
Event key
0
Event type
3
Date of event
2010-08-18
Date received
2010-09-14
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
ERIC KOLODZIEJ
Address
9115 HAGUE ROAD INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANALYTICAL P MODULECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSDKH03738965001R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-09-140

Event Narratives#

D

Patient 1

THE USER RECEIVED QUESTIONABLE RESULTS FOR PHENYTOIN ON THE ANALYTICAL P MODULE ON TWO SAMPLES COLLECTED FROM THE SAME PATIENT. THE INITIAL RESULT FOR PHENYTOIN WAS 0.0 UG/ML. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER WHICH GAVE A RESULT OF 0.0 UG/ML. BOTH THE INITIAL AND REPEAT RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE USER SAID PER THEIR LAB POLICY, IF A PHENYTOIN RESULT IS < 0.6 UG/ML, THEN THEY WILL REPORT OUT A RESULT OF < 0.6 UG/ML. THE USER REPORTED OUTSIDE THE LABORATORY A PHENYTOIN RESULT OF < 0.6 UG/ML FOR THIS PATIENT SAMPLE. THE USER SENT AN ALIQUOT OF THE ORIGINAL PATIENT SAMPLE TO ANOTHER FACILITY FOR REPEAT ANALYSIS WHICH YIELDED A PHENYTOIN RESULT OF 25.8 UG/ML. THE METHOD OR ANALYZER USED FOR REPEAT TESTING WAS NOT PROVIDED. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2010 WHICH GAVE AN INITIAL PHENYTOIN RESULT OF 0.0 NG/ML. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE P MODULE GIVING 0.0 NG/ML. BOTH THE INITIAL AND REPEAT RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE USER REPORTED OUTSIDE THE LABORATORY A PHENYTOIN RESULT OF < 0.6 UG/ML FOR THIS PATIENT SAMPLE. THE USER SENT AN ALIQUOT OF THE SECOND SAMPLE TO ANOTHER FACILITY FOR REPEAT ANALYSIS ON AN INTEGRA ANALYZER. THE REPEAT PHENYTOIN RESULT WAS 33.1 UG/ML. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THESE DISCREPANCIES. THE USER DECLINED A FIELD SERVICE DISPATCH. USER SAID THEY BELIEVED THIS INCIDENT TO BE PATIENT SAMPLE RELATED. THE PHENYTOIN REAGENT LOT NUMBER WAS 14829200. USER SAID PATIENT SAMPLES ARE AVAILABLE FOR FURTHER INVESTIGATION.

N

Patient 1

.

D

Patient 1

.

N

Patient 1

DATA PROVIDED INDICIATED ALL CONTROL LEVELS RECOVERED ACCEPTABLY. ON THE BASIS OF THE CONTROL RECOVERY AND INVESTIGATION OF THE RETURNED SAMPLES IT CAN BE CONCLUDED THAT THE ONLINE PHENYTOIN APPLICATION IS PERFORMING ACCEPTABLY ON THE MODULAR P ANALYZER. THE EXTREMELY LOW PHENYTOIN RECOVERIES FOR THE PATIENT DRAWS (BELOW 0 UG/ML) ARE DUE TO NON-SPECIFIC AGGLUTINATION PRODUCED BY SOME UNKNOWN COMPONENT PRESENT IN THE PATIENT SAMPLE. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING. NO ADVERSE EVENTS IN RELATION TO THE FALSELY LOW PHENYTOIN RESULT WERE REPORTED.