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 2017-08-22 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.

Event Text Entries

[84082610] (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[84082611] The customer stated that they noticed questionable results for some patient samples tested for alb2 albumin gen. 2 (alb) on the cobas 8000 c (701) module - c701. This prompted them to repeat 1000 patient samples. The customer provided data for two patient samples that were questioned. Of these, one had an erroneous result. The erroneous result was not reported outside of the laboratory. The customer also stated that they were seeing erratic behavior for the enzymatic creatinine test run on the other disk of the analyzer. No further details were provided regarding this. The sample initially resulted with an alb value of 58. 6 g/l. The sample was repeated on (b)(6) 2017, resulting as 39. 3 g/l. The sample was also repeated on (b)(6) 2017, resulting as 40. 8 g/l. No adverse events were alleged to have occurred with the patient. The customer ran precision studies. The customer changed all reagent and sample probes. These actions did not resolve the issue. The field service engineer checked washing on the analyzer and this was ok. He checked gear pump pressure and probe washing and these were ok. He checked the high concentration vacuum and pressure was a bit low. He replaced a valve and damaged tubing. Calibration and quality controls were ok. The issue was due to aging of the replaced valve.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-01788
MDR Report Key6809926
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-08-22
Date of Report2017-08-22
Date of Event2017-08-01
Date Mfgr Received2017-08-03
Date Added to Maude2017-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 CodeCJW
Date Received2017-08-22
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 Received2017-08-22
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 2017-08-22

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