COBAS 8000 C 702 MODULE C702 06473245001

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 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.

Event Text Entries

[93373274] (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[93373275] The customer initially complained of erroneous high results for 2 patient samples tested for albumin on a cobas 8000 c 702 module. Patient 1 initial albumin result was 104. 5 g/l. The sample was repeated on another instrument in the laboratory and the result was 44. 1 g/l. Patient 2 initial albumin result was 73. 1 g/l. The sample was repeated on another instrument in the laboratory and the result was 40. 7 g/l. It is not known if the erroneous results for these 2 patient samples were reported outside of the laboratory. The customer provided additional results for 16 patient samples that were tested for albumin, creatinine, urea or uric acid. Based on the data provided, the results for 7 patient samples were erroneous when tested for albumin, uric acid or creatinine. The erroneous result for 1 patient tested for creatinine was reported outside of the laboratory and corrected following the repeat test. There was no allegation that an adverse event occurred. No reagent lot numbers or expiration dates were provided. The field service engineer (fse) visited the customer site on 03-nov-2017 and found a dripping cell cleaner nozzle on one of the rinse units. The nozzle and tubing was flushed and the one-way valve was checked and replaced. During a review of the reaction monitor, an issue was observed that appears to be carryover or dripping into the cuvette. This corresponds to the fse finding of the dripping cleaner nozzle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-02632
MDR Report Key7037717
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-11-16
Date of Report2017-12-06
Date of Event2017-10-23
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 C 702 MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeCJW
Date Received2017-11-16
Model NumberC702
Catalog Number06473245001
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 C 702 MODULE
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-11-16
Model NumberC702
Catalog Number06473245001
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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