COBAS 8000 C (701) MODULE C701 05641489001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-14 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.

Event Text Entries

[86590650] This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[86590651] The customer complained of erroneous results for 1 patient sample tested for igg-2 tina-quant igg gen. 2 (igg-2) on a cobas 8000 c (701) module. The date of event is an approximation. The customer did not provide the date of event. The initital igg-2 result was 25. 9 (unit of measure not provided) with a data flag. The sample was repeated by auto-dilution and the result was 18. 1. The customer stated this result was "transmitted. " it is not clear where this result was transmitted. It is not clear which of the customer's results were believed to be correct. The sample was tested by electrophoresis and the result was 33. 9 g/l. There was no allegation that an adverse event occurred. The igg-2 reagent lot number and expiration date were not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-01990
MDR Report Key6865974
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-09-14
Date of Report2017-11-13
Date of Event2017-08-25
Date Mfgr Received2017-08-25
Date Added to Maude2017-09-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1HITACHI HIGH TECH CORP.
Manufacturer Street882 ICHIGE HITACHINAKA NA
Manufacturer CityIBARAKI 312-8504
Manufacturer CountryJA
Manufacturer Postal Code312-8504
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameCOBAS 8000 C (701) MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeCFQ
Date Received2017-09-14
Model NumberC701
Catalog Number05641489001
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457

Device Sequence Number: 1

Brand NameCOBAS 8000 C (701) MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-09-14
Model NumberC701
Catalog Number05641489001
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-14

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