MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for potassium on a roche 9180 electrolyte analyzer.The sample resulted with a potassium value of 6.7 mmol/l when tested on the 9180.The sample was repeated on an istat analyzer, resulting as 4.6 mmol/l.Both values were reported outside of the laboratory to the doctor.No adverse events were alleged to have occurred with the patient.The potassium electrode lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

No qc results or data were provided.The product was requested for investigation but not returned.The customer continued using the affected electrode, and there were no further issues.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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 Key: 7752893
• MDR Text Key: 116872936
• Report Number: 1823260-2018-02623
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (y/n): N
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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
• Device Operator: Health Professional
• Device Model Number: ISE 9180
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1