MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number 03107019001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).The event occurred in: (b)(6).

Event Description

The customer received questionable ise indirect na for gen.2 results for 3 patient samples on a roche 9180 electrolyte analyzer ((b)(4)) compared to two cobas 6000 c (501) modules.Of the data provided, there were discrepant sodium results for 2 patient samples.Patient 1 ise 9180 sodium results were 156 mmol/l with a repeat result of 157 mmol/l.The sodium results from one c501 were 166 mmol/l with a repeat result of 163 mmol/l.The sodium results from the other c501 were 161 mmol/l with a repeat result of 161 mmol/l.Patient 2 ise 9180 sodium results were 143 mmol/l with a repeat result of 143 mmol/l.The sodium results from one c501 were 149 mmol/l with a repeat result of 145 mmol/l.The sodium results from the other c501 were 146 mmol/l with a repeat result of 146 mmol/l.The erroneous results from the (b)(4) were not reported outside of the laboratory.The results from the cobas c501 analyzer were reported outside of the laboratory.There was no allegation of an adverse event.The field engineering specialist tested both the ise high and the ise low calibrators on the two cobas c501s compared to the (b)(64.The cobas c501 results were higher that the (b)(4).The reference electrode was exchanged without any improvement to the situation.The investigation is currently ongoing.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• 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: 7568510
• MDR Text Key: 110044477
• Report Number: 1823260-2018-01732
• Device Sequence Number: 1
• Product Code: JFP
• 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: 08/23/2018

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: 03107019001
• Device Catalogue Number: 03107019001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1