• 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 ISE INDIRECT CI FOR GEN.2; ELECTRODE, ION-SPECIFIC, CHLORIDE

  • 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 ISE INDIRECT CI FOR GEN.2; ELECTRODE, ION-SPECIFIC, CHLORIDE Back to Search Results
Catalog Number ASKU
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
The field service engineer determined there was a failure of the ise electrodes.The ise flow path was cleaned, the sipper nozzle was replaced, the cell rinse mechanism was tightened, squeegees were aligned, and system reagents were replaced.The customer ran calibration and controls; results were within laboratory guidelines.Precision studies were performed and recovered within guidelines.The investigation determined that the service actions resolved the issue.
 
Event Description
The initial reporter stated that they received questionable results for one patient sample tested for multiple assays on the cobas 6000 c (501) module.Of the mentioned assays, the sample had discrepant results for ise indirect na, k, ci for gen.2.No incorrect results were reported outside of the laboratory.The samples were repeated on a second c501 analyzer and the repeat results were believed to be correct.This medwatch will apply to the cl electrode.Please refer to the medwatch with patient identifier (b)(6) for information related to the na electrode and refer to the medwatch with patient identifier (b)(6) for information related to the k electrode.The sample initially resulted with an na value of 91 mmol/l, which repeated as 138 mmol/l.The sample initially resulted with a k value of 2.6 mmol/l, which repeated as 4.0 mmol/l.The sample initially resulted with a cl value of 68 mmol/l, which repeated as 108 mmol/l.No adverse events were alleged to have occurred with the patient.The c501 analyzer serial number is (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ISE INDIRECT CI FOR GEN.2
Type of Device
ELECTRODE, ION-SPECIFIC, CHLORIDE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key8736546
MDR Text Key149379338
Report Number1823260-2019-02335
Device Sequence Number1
Product Code CGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/07/2019
Initial Date FDA Received06/26/2019
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 N
Patient Sequence Number1
Patient Age75 YR
-
-