• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER Back to Search Results
Model Number E601
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
Analysis of qc testing showed no indication of a general system or reagent issue. Foam was found on the sample. An exact root cause could not be determined. Other possible root causes include tilted tubes in combination with wet tube walls or fibrin clots or strands caused by insufficient pre-analytical handling.
 
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
The customer complained of a discrepant result for elecsys ca 19-9 immunoassay (ca 19-9) result for one patient sample. The customer sent the patient sample out to an external laboratory and the discrepant result was generated by their cobas 6000 e 601 module (e601). The patient had an initial (sample 1) ca 19-9 result of 200 u/ml on (b)(6) 2017. Sample 1 initial result was not reported outside of the laboratory. Sample 1 was repeated and a result of 198 u/ml was obtained which was deemed correct. The testing was performed on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170). The patient mentioned that they went to another hospital or laboratory and they had a result that meets expectations. Specific information regarding which system and an exact results could not be obtained. A new blood draw was performed on (b)(6) 2017 (sample 2). Sample 2 was tested for ca 19-9 on a cobas 8000 e 801 module and an initial result of 315 u/ml and a repeat result of 317 u/ml was obtained. The initial result was not reported outside of the laboratory. Sample 2 was sent to an external laboratory (lab 1). Lab 1 tested sample 2 for ca 19-9 on an e601 on (b)(6) 2017. The ca 19-9 result was 3 u/ml. Sample 2 was sent to another external laboratory (lab 2) and ca 19-9 testing was performed on a siemens system. A ca 19-9 result of 70 u/ml was obtained. The expected value for the competitor system was < 30 u/ml. Sample 2 was sent to another external laboratory (lab 3). Lab 3 tested sample 2 for ca 19-9 on a e601 on (b)(6) 2017. The ca 19-9 result was 291. 5 u/ml sample 2 was sent to another external laboratory (lab 4). Lab 4 testing was performed on (b)(6) 2017 and a ca 19-9 result of 307 u/ml was obtained from an unknown system. Unless noted all results were reported outside of the laboratory. For sample 2 the correct result was deemed to be around 300 u/ml. There was no allegation of an adverse event. The ca 19-9 reagent lot was 21361200 with an expiration date of 31-oct-2018. The investigation is currently ongoing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOBAS 6000 E 601 MODULE
Type of DeviceIMMUNOCHEMISTRY ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
na
ibaraki 312-8 504
JA 312-8504
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key6968390
MDR Text Key251404074
Report Number1823260-2017-02399
Device Sequence Number0
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE601
Device Catalogue Number04745922001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage

-
-