FDA.reportPublic FDA data

MAUDE MDR 1755851

MDR report key
1755851
Report number
1823260-2010-04173
Event key
0
Event type
3
Date of event
2010-06-21
Date received
2010-07-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
105
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
1COBAS INTEGRA 800CLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSJFM28122474001R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-07-140

Event Narratives#

D

Patient 1

USER RECEIVED QUESTIONABLE TOTAL BILIRUBIN RESULTS ON TWO DIFFERENT SAMPLES OBTAINED FROM THE SAME NEWBORN BABY, ON THE INTEGRA 800 (I800) ANALYZER. THE FIRST SAMPLE WAS ORIGINALLY RUN ON THE COBAS 6000 (C501) ANALYZER. THE INITIAL BILIRUBIN RESULT GAVE 20 MG/DL ON THE C501 ANALYZER. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED THE LABORATORY AND QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THIS I800 ANALYZER GIVING 12.7 MG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS ADDITIONALLY REPEATED ON THE C501 ANALYZER GIVING 16.1 MG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. A SECOND SAMPLE WAS OBTAINED FROM THE SAME NEWBORN BABY AND WAS INITIALLY TESTED ON THIS I800 ANALYZER GIVING A TOTAL BILIRUBIN RESULT OF 12.6 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON THIS ANALYZER GIVING 12.4 MG/DL. THE SAMPLE WAS ADDITIONALLY REPEATED ON THE C501 ANALYZER GIVING 15.8 MG/DL. BOTH REPEAT RESULTS WERE ACCOMPANIED BY DATA FLAGS. USER WAS NOT SURE WHICH TOTAL BILIRUBIN RESULTS WERE THE CORRECT RESULTS. THE USER SAID THE NEWBORN BABY WAS TREATED WITH "BILI LIGHTS" BUT DID NOT BELIEVE THIS HAD AN ADVERSE AFFECT. USER HAD NOT BEEN INFORMED OF ANY ADVERSE AFFECT TO THE NEWBORN BABY. TOTAL BILIRUBIN REAGENT LOT WAS 625727. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE A CAUSE. HE CHECKED INSTRUMENT FUNCTION AND RAN QUALITY CONTROL. CUSTOMER RAN PRECISION USING THE SAME SAMPLE MATERIAL ON BOTH THE I800 AND C501 ANALYZERS.

N

Patient 1

IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA. COBAS 6000 C501 ANALYZER IS REPORTED IN ANOTHER MDR (B)(6).

N

Patient 1

FURTHER INVESTIGATION WAS NOT POSSIBLE DUE TO MISSING ESSENTIAL INFORMATION. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE EXACT CLINICAL INFORMATION REGARDING THE PATIENT WAS NOT PROVIDED. THE PHOTOTHERAPY THAT WAS PERFORMED, BASED ON THE FIST ELEVATED TOTAL BILIRUBIN RESULT FROM THE COBAS 6000 C501, MIGHT HAVE BEEN UNNECESSARY. THE PHOTOTHERAPY WAS CANCELLED EIGHT HOURS LATER. THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS WERE REPORTED.

D

Patient 1

IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE SURGEON HAS COMPLAINED ABOUT COAGULATION ABILITY FOR THIS DEVICE DUE TO HAND CONTROL ACTIVATION. AND THEY REPLACED THE HAND PIECE AND FOCUS, BUT HE STILL COMPLAINED ABOUT IT. SURGERY WAS PROLONGED TEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.