COBAS INTEGRA ALKALINE PHOSPHATASE 0766739

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-09-18 for COBAS INTEGRA ALKALINE PHOSPHATASE 0766739 manufactured by Roche Diagnostics.

Event Text Entries

[198874] The customer loaded and ran one reagent cassette on one analyzer. The customer then took this reagent cassette off of this analyzer and loaded onto another analyzer and ran several pt samples. The analyzer recognized this cassette as a new reagent cassette. 7 patient samples recovered falsely zero. No results were reported for pt treatment. Samples were return. These values were reported for pt treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2000-00194
MDR Report Key297158
Report Source05
Date Received2000-09-18
Date of Report2000-09-12
Date of Event2000-03-14
Date Mfgr Received2000-03-14
Device Manufacturer Date1999-08-01
Date Added to Maude2000-09-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDEBARA REEK
Manufacturer Street9115 HAGUE RD.
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175763857
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOBAS INTEGRA ALKALINE PHOSPHATASE
Generic NameLABORATORY CLINICAL CHEMISTRY CASSETTE
Product CodeCJE
Date Received2000-09-18
Model NumberNA
Catalog Number0766739
Lot Number61013501
ID NumberNA
Device Expiration Date2001-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key287636
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD INDIANAPOLIS IN 46250 US
Baseline Brand NameCOBAS INTEGRA ALKALINE PHOSPHATASE
Baseline Generic NameLABORATORY CLINICAL CHEMISTRY CASSETTE
Baseline Model NoNA
Baseline Catalog No0766739
Baseline IDNA
Baseline Device FamilyINTEGRA FAMILY OF ANALYZERS
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]18
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK981897
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-09-18

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