COBAS 8000 E 602 MODULE E602

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 2017-04-14 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.

Event Text Entries

[72880361] Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[72880362] The customer received questionable high cyclosporine results for one patient sample. The initial result was >2000 ng/ml. The customer repeated same sample with a 1:3 dilution and the result was >6000 ng/ml. The customer reported the results outside the laboratory and discussed the results with a physician. The physician then collected a new specimen from the patient and the result was 242. 2 ng/ml. There was no allegation of an adverse event. The reagent lot number was 15079900. The expiration date was requested but was not provided. There were no alarms or error flags with the questionable results.
Patient Sequence No: 1, Text Type: D, B5


[79154229] A specific root cause could not be determined. A general issue with the cyclosporine reagent was not suspected based on the provided qc data. Investigation of the event determined the most likely cause was a handling issue, such as foam or air bubbles on the reagent surface, or an issue with the collection or condition of the patient sample.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2017-00777
MDR Report Key6493653
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-04-14
Date of Report2017-06-12
Date of Event2017-03-21
Date Mfgr Received2017-03-28
Date Added to Maude2017-04-14
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 E 602 MODULE
Generic NameIMMUNOCHEMISTRY ANALYZER
Product CodeLTB
Date Received2017-04-14
Model NumberE602
Catalog NumberASKU
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 E 602 MODULE
Generic NameIMMUNOCHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-04-14
Model NumberE602
Catalog NumberASKU
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2017-04-14

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