FDA.reportPublic FDA data

MAUDE MDR 1778052

MDR report key
1778052
Report number
1823260-2010-04557
Event key
0
Event type
3
Date of event
2010-07-21
Date received
2010-07-30
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COBAS 6000 CORECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCJO04745868001R Y
1236980COBAS 6000 CORECLINICAL CHEMISTRY ANALYZERROCHE DIAGNOSTICSCJO04745868001Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-07-300

Event Narratives#

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ALKALINE PHOSPHATASE (ALP) ON THE COBAS 6000 CORE ANALYZER FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FOR ALP WAS 411 U/L. THIS RESULT WAS FLAGGED WITH A DELTA CHECK BY THE CUSTOMER'S LABORATORY INFORMATION SYSTEM. THE SAMPLE WAS REPEATED WHICH GAVE A RESULT OF 140 U/L. THE CUSTOMER COULD NOT REPRODUCE THE INITIAL RESULT FOR ALP. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT TREATED BASED ON THE INITIAL RESULT. CALCIUM REAGENT LOT NUMBER, 622035.

D

Patient 1

DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2010-02425.

N

Patient 1

IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA. THIS EVENT OCCURRED IN (B)(6).

N

Patient 1

INVESTIGATION OF THE DATA PROVIDED INDICATED A POSSIBLE CAUSE FOR THE HIGH ALP RESULT WAS CARRY-OVER OF PARTICULATES, SUCH AS FIBRIN CLOTS OR LEUKOCYTES, BY THE SAMPLE PROBE. THESE PARTICULATES MAY HAVE BEEN PRESENT BECAUSE OF THE SHORT SAMPLE CENTRIFUGATION TIME USED BY THE CUSTOMER. THE TUBE MANUFACTURER RECOMMENDS SPINNING THE SAMPLE FOR AT LEAST 10 MINUTES, THE CUSTOMER WAS ONLY SPINNING SAMPLES FOR 7 MINUTES. THE PATIENT WAS NOT AFFECTED BY THE EVENT.