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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The investigation is ongoing.
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested for chloride on the roche 9180 electrolyte analyzer.Before patient testing, qc was acceptable for level 1 and level 2.The customer's level 3 qc was out of acceptable range.At 14:46, the patient's initial chloride result was 130 mmol/l with a data flag.At 14:48, the patient's repeat chloride result was 106 mmol/l.The chloride electrode lot number was 21500348 with an expiration date requested but not provided.
 
Manufacturer Narrative
The chloride electrode used onboard the instrument was sent for further investigation.The electrode was tested for several days and the calibration and qc recovery were both found to be acceptable.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 Key10852544
MDR Text Key242856519
Report Number1823260-2020-02923
Device Sequence Number1
Product Code JFP
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 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
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 Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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