FDA.reportPublic FDA data

MAUDE MDR 6718776

MDR report key
6718776
Report number
1823260-2017-01467
Event key
0
Event type
3
Date of event
2017-06-18
Date received
2017-07-17
Adverse event
0
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
0COBAS INTEGRA 400 PLUSCLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCITI400+ASKUNAR Y
1COBAS INTEGRA 400 PLUSCLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJJEI400+ASKUNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-170

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). (B)(4). MEDWATCH CONCOMITANT MEDICATION - ADDITIONAL MEDICATION INCLUDES: POTASSIUM CHLORIDE 6% AND PIPERACILLIN + TARZOBACTAM (PATIENT 2) ONCE DAILY. (B)(6).

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR THREE PATIENT SAMPLES TESTED FOR ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) AND ALTL ALANINE AMINOTRANSFERASE ACC. TO IFCC (ALT) ON A COBAS INTEGRA 400 PLUS (I400+). AN ERRONEOUS AST RESULT FROM THE FIRST PATIENT WAS REPORTED OUTSIDE OF THE LABORATORY. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY OTHER ERRONEOUS RESULTS FROM THE PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY. ROCHE MANUFACTURES TWO DIFFERENT ALT REAGENTS FOR USE WITH THE I400+. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH SPECIFIC REAGENT WAS USED DURING THE EVENT. THE FIRST SAMPLE INITIALLY RESULTED WITH AN AST VALUE OF 1627.3 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 WITH SALINE AND REPEATED, RESULTING AS 16500.2 U/L ACCOMPANIED BY A DATA FLAG. THE 16500.2 U/L VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2017 ON A SIEMENS DIMENSION RXL MAX ANALYZER, RESULTING AS 1684 U/L. THE 1684 U/L VALUE WAS BELIEVED TO BE CORRECT AND WAS RELEASED TO THE PATIENT. THIS SAMPLE ALSO INITIALLY RESULTED WITH AN ALT VALUE OF 1442.7 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 WITH SALINE AND REPEATED, RESULTING AS 14500.3 ACCOMPANIED BY A DATA FLAG. FOR THE SECOND SAMPLE, FROM A (B)(6) YEAR OLD FEMALE PATIENT, INITIALLY THE ANALYZER DID NOT PRODUCE A NUMERIC AST RESULT ON (B)(6) 2017. THE SAMPLE WAS DILUTED 1:20 WITH SALINE AND REPEATED THREE TIMES, RESULTING AS 5606.4 U/L, 3426.0 U/L, AND 5531.9 U/L ON (B)(6) 2017. THE THIRD SAMPLE, FROM A (B)(6) YEAR OLD MALE PATIENT, INITIALLY RESULTED WITH AN AST VALUE OF > 700.0 U/L ACCOMPANIED BY A DATA FLAG ON (B)(6) 2017. THIS SAME MEASUREMENT WAS ALSO DOCUMENTED WITH A VALUE OF 916.5 U/L. A CLARIFICATION OF THESE VALUES HAS BEEN REQUESTED. THE SAMPLE WAS DILUTED 1:5 WITH SALINE AND REPEATED, RESULTING WITH AN AST VALUE OF 4510.3 U/L ACCOMPANIED BY A DATA FLAG ON (B)(6) 2017. THE SAMPLE WAS TESTED ON THE SIEMENS DIMENSION RXL MAX ANALYZER, RESULTING WITH AN AST VALUE OF 886.96 ON (B)(6) 2017. THE CUSTOMER ALSO PROVIDED THE FOLLOWING AST VALUES. IT IS UNCLEAR IF THESE RESULTS ARE FROM ONE OR MULTIPLE SAMPLES AND IF THESE ARE FROM ONE OF THE PREVIOUSLY MENTIONED PATIENTS OR A NEW PATIENT: 16823 U/L ON (B)(6) 2017 MEASURED ON I400+. >20.000 U/L ON (B)(6) 2017 MEASURED ON I400+ AND LABELED AS "SECOND SAMPLE". 3585 U/L ON (B)(6) 2017 MEASURED ON SIEMENS DIMENSION RXL MAX ANALYZER AND LABELED AS "FIRST SAMPLE". 5824 U/L ON (B)(6) 2017 MEASURED ON SIEMENS DIMENSION RXL MAX ANALYZER AND LABELED AS "SECOND SAMPLE". CLARIFICATION OF THESE VALUES HAS BEEN REQUESTED. NO ADVERSE EVENTS WERE ALLEGED. THE AST REAGENT LOT NUMBER WAS 19549601, WITH AN EXPIRATION DATE OF 01/31/2018. THE ALT REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE DATABASE HELD MORE THAN THE MAXIMUM ALLOWABLE AMOUNT OF DATA. WITH THIS AMOUNT OF DATA, THE ANALYZER MAY BE SLOW OR UNABLE TO GENERATE CORRECT RESULTS AS THE CALCULATOR/PC IS OVERLOADED. THE CUSTOMER WAS NOT PURGING THE DATA ON A DAILY BASIS. THIS CAN LEAD A MALFUNCTION OF THE DATABASE.

N

Patient 1

IT HAS BEEN CLARIFIED THAT ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR ALL PATIENTS.

N

Patient 1

FOR THE THIRD PATIENT SAMPLE, THE INITIAL AST MEASUREMENT RESULTS WERE BOTH > 700.0 U/L AND 916.5 U/L. THE SOFTWARE CONFIGURATION WAS CHECKED DURING INVESTIGATIONS AND AN INCORRECT DATA FLAGGING CONFIGURATION WAS FOUND. IT WAS OBSERVED THAT THE CUSTOMER WAS USING AN OLDER TEST IDENTIFIER USED FOR AN OLDER TEST APPLICATION VERSION. THE CURRENT TEST APPLICATION VERSION USED BY THE CUSTOMER WAS ASKED FOR, BUT NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED.