COBAS INTEGRA 400 PLUS 03245233001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-06-18 for COBAS INTEGRA 400 PLUS 03245233001 manufactured by Roche Diagnostics.

Event Text Entries

[1259200] The user experienced the calcium qc drifting lower since (b) (6) 2009 and received discrepant calcium results on (b) (6) 2009 for two patient samples in lithium heparin tubes. Patient 1 original result was 8. 0 mg per dl and was reported. The user repeated the sample with results of 8. 1 and 8. 0 mg per dl. After the user changed to a new lot number of reagent the sample was repeated the same day and a corrected report of 9. 1 mg per dl was sent out. Patient 2 original result was 7. 8 mg per dl and was reported. The user repeated the sample with a result of 7. 9 mg per dl twice. After the user changed to a new lot number of reagent the sample was repeated the same day and a corrected report of 8. 8 mg per dl was sent out. The user stated these 2 patients are receiving infusion therapy for osteoporosis. As a result of the original calcium result for patient 2, the patient did not receive the infusion at that time because they believed her calcium level to be too low. The user stated that patient is to come back in for a repeat calcium test and that time will be evaluated regarding getting an infusion. The user stated this patient also had a low vitamin d level which also precluded her from having the infusion so the user did not consider the low calcium value as the only reason she did not have the infusion. The user did not consider this calcium result to have an adverse affect on the patient. The user stated since utilizing the new lot number of reagent, she does not believe she has had any further problems with patient results. The field service representative agreed the reagent was the cause and performed check tests on the analyzer to verify performance.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2009-04278
MDR Report Key1461839
Report Source05,06
Date Received2009-06-18
Date of Report2009-06-18
Date of Event2009-05-27
Date Facility Aware2009-05-28
Report Date2009-05-28
Date Mfgr Received2009-05-28
Date Added to Maude2010-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactERIC KOLODZIEJ
Manufacturer Street9115 HAGUE RD.
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175212834
Manufacturer G1ROCHE INSTRUMENT CETNER AG
Manufacturer StreetFORRENSTRASSE TEGIMENTA
Manufacturer CityROTKREUZ
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOBAS INTEGRA 400 PLUS
Generic NameCLINICAL CHEMISTRY ANALYZER - JJE
Product CodeJFP
Date Received2009-06-18
Catalog Number03245233001
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer AddressINDIANAPOLIS IN US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-06-18

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