• 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 C501 MODULE CLINICAL CHEMISTRY 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 C501 MODULE CLINICAL CHEMISTRY ANALYZER Back to Search Results
Model Number C501
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer complained of an erroneous high result for 1 patient tested for nh3l ammonia (nh3l). The erroneous result was reported outside of the laboratory. The initial nh3l result was 610. 0 umol/l from the c501 analyzer. This result was reported outside of the laboratory where the doctor questioned it. A second sample was obtained and the result from a second c501 analyzer was 83. 3 umol/l. The initial sample was repeated on the first c501 analyzer even though it was no longer on ice and the result was 76. 7 umol/l. The initial sample was also repeated on the second c501 analyzer and the result was 71 umol/l. No adverse event occurred. The nh3l reagent lot number was 12955701 with an expiration date of 07/31/2017. The customer replaced the reaction cells before the event on (b)(6) 2016 and after the event on (b)(6) 2016. The field service engineer (fse) visited the customer site and checked multiple parts of the analyzer. Vacuum pump diaphragms were also checked and replaced even though they were not worn through. All analyzer specifications were within the appropriate guidelines and no adjustments were required. The fse ran precision tests and repeated the original sample in question 5 times. The results were repeated with no erroneous high results. Quality controls (qc) were acceptable and the customer began to run patient samples again. A specific root cause could not be identified. Additional information was requested for investigation, but was not provided. Based on the information available for investigation, an instrument and reagent issue can be excluded since calibration and qc were acceptable. The instrument was also checked by the fse and no issues were identified. Based on a review of the reaction monitor, the most likely root cause is a carry-over issue because the reaction curve provided for the initial result decreased abnormally.

 
Manufacturer Narrative

The customer has not had any further issues since the reaction cells were replaced on (b)(6) 2016 and the service visit by the fse.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOBAS 6000 C501 MODULE
Type of DeviceCLINICAL CHEMISTRY 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 Key6033650
MDR Text Key57629412
Report Number1823260-2016-01581
Device Sequence Number0
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2016
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC501
Device Catalogue Number05860636001
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 Received09/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-