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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER
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ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER Back to Search Results
Model Number ISE 9180
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer complained of discrepant ise indirect na for gen.2 results for 1 patient sample on a roche 9180 electrolyte analyzer compared to an elyte instrument.The na result was 132 mmol/l on the 9180 electrolyte analyzer.The na result was 141 mmol/l on the elyte instrument.There was no allegation of an adverse event.No erroneous results were reported outside of the laboratory.The customer performed daily maintenance and calibration.The customer repeated the sample.The repeat na result was 137 mmol/l on the 9180 electrolyte analyzer and 142 mmol/l on the elyte instrument.The na electrode lot number and expiration date were not provided.
 
Manufacturer Narrative
The reference electrode was installed (b)(6) 2018.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
ROCHE 9180 ELECTROLYTE ANALYZER
Type of Device
ELECTROLYTE ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7877768
MDR Text Key120398827
Report Number1823260-2018-03149
Device Sequence Number1
Product Code JFP
UDI-Device Identifier04015630028702
UDI-Public4015630028702
Combination Product (y/n)N
PMA/PMN Number
K961458
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberISE 9180
Device Catalogue NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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