MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number	ISE 9180
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem 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.
Additional 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.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Common Device Name: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7877768
• Report Number: 1823260-2018-03149
• Device Sequence Number: 16663249
• Product Code: JFP
• UDI-Device Identifier: 04015630028702
• UDI-Public: 4015630028702
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K961458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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
• Operator of Device: Health Professional
• Device Model Number: ISE 9180
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1