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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE (DOUBLE); CLINICAL CHEMISTRY ANALYZER
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ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE (DOUBLE); CLINICAL CHEMISTRY ANALYZER Back to Search Results
Model Number COBAS 8000 ISE
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer received questionable ise indirect na, k, ci for gen.2 results for multiple patient samples from the cobas 8000 cobas ise module.Only the following data was provided for three patient samples.Sample 1 initial chloride result was 150 mmol/l and the repeat result was 103 mmol/l.Sample 2 initial sodium result was 129 mmol/l and the repeat result was 141 mmol/l.The initial potassium result was 4.4 mmol/l and the repeat result was 4.9 mmol/l.The initial chloride result was 115 mmol/l and the repeat result was 103 mmol/l.Sample 3 initial sodium result was 157 mmol/l and the repeat result was 143 mmol/l.The initial chloride result was 91 mmol/l and the repeat result was 105 mmol/l.The erroneous results were not reported outside of the laboratory.The repeat results were believed to be correct.There was no adverse event.The electrode lot numbers and expiration dates were requested but were not provided.The field service representative found the syringe seals were very worn and the sipper nozzle was not fully aspirating from the dilution vessel.He replaced the syringe seals, sipper nozzles, sipper tubes and pinch tubings.He cleaned the waste flow path, including the tubing, valves, and system reagent flow path.He conditioned the electrodes and performed reagent primes.The customer ran calibration, qc, and correlations which were within specifications.Further investigation was unable to find a definitive root cause.
 
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Brand Name
COBAS 8000 COBAS ISE MODULE (DOUBLE)
Type of Device
CLINICAL 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 Key7645098
MDR Text Key112568672
Report Number1823260-2018-02088
Device Sequence Number1
Product Code JJE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCOBAS 8000 ISE
Device Catalogue Number05964075001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/11/2018
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
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