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 2017-11-16 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.

Event Text Entries

[93355865] This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[93355866] The customer complained of erroneous results for 1 patient sample tested for elecsys free psa immunoassay (free psa) on 3 cobas 8000 e 602 modules. Results were not reported outside of the laboratory. It is not known which results were believed to be correct. This medwatch will cover e602 module serial (b)(4). The initial free psa result on e602 module with serial number (b)(4) was 0. 011 ng/ml. The sample was repeated on e602 module serial number (b)(4) and the result was 0. 671 ng/ml. The sample was repeated on e602 module serial number (b)(4) and the result was 0. 787 ng/ml. Based on the data provided, there is an additional patient sample with erroneous free psa results. It is not clear whether this additional sample is from the 1 patient the customer complained about or if this is for a different patient. It is also not known which e602 module produced the results. Clarification on this has been requested but has not been provided. The initial free psa result was 0. 01 ng/ml. The repeat result was 0. 395 ng/ml. It is not known which result is believed to be correct. This information was requested but has not been provided. There was no allegation that an adverse event occurred. The free psa reagent lot number and expiration date were not provided. A specific root cause was not identified. Additional information was requested for investigation but was not provided. The customer has not provided any additional information related to this event, therefore the investigation could not be completed. A general product problem is excluded.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-02634
MDR Report Key7037790
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-11-16
Date of Report2017-11-16
Date of Event2017-10-26
Date Mfgr Received2017-10-26
Date Added to Maude2017-11-16
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 CodeLTJ
Date Received2017-11-16
Model NumberE602
Catalog NumberASKU
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 E 602 MODULE
Generic NameIMMUNOCHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-11-16
Model NumberE602
Catalog NumberASKU
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 2017-11-16

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