MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The initial reporter stated they received a discrepant result for one patient tested for ionized calcium on the 9180 electrolyte analyzer.On the night of (b)(6) 2020, the reporter stated there were issues with calibration of the 9180 analyzer and a system reagent pack had leaked.Cleaning was performed and the reporter continued to try recalibrating until calibration was successful.The sample initially resulted with an ionized calcium value of 1.52 mg/dl when tested on the 9180 analyzer.The patient had no previous results, so the sample was repeated on an abl 800 gasometer, resulting with an ionized calcium value of 5.04 mg/dl.This value was considered correct and released to the doctor.The ionized calcium electrode lot number and expiration date were requested, but not provided.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Type of Device: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10142439
• MDR Text Key: 194782663
• Report Number: 1823260-2020-01424
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 MO