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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 High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2018
Event Type  malfunction  
Event Description
The customer received questionable calcium results from the electrolyte analyzer 9180 that would be 10x the normal result.One example was provided.The results for one sample were 0.44 mmol/l, 0.44 mmol/l and 4.68 mmol/l.The result of 0.44 mmol/l was believed to be correct.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.All qc results were in the acceptable range.The customer replaced all the electrodes, all tubing, and snapack.However, the issue was not resolved.The customer then changed the calcium electrode and ran a 20 specimen validation.
 
Manufacturer Narrative
The customer was sent a replacement instrument.The mainboard from the affected system was returned to roche diagnostics for further investigation.The issue could not be reproduced.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 Key7973214
MDR Text Key123946080
Report Number1823260-2018-03711
Device Sequence Number1
Product Code JFP
UDI-Device Identifier04015630031832
UDI-Public04015630031832
Combination Product (y/n)N
PMA/PMN Number
K961458
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberISE 9180
Device Catalogue Number03157334001
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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