MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number I400+

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable high ise indirect for gen.2 chloride results for multiple samples over two days.He changed the electrode, the calibrator solution, the reference electrode, and the mix tower but the results were still high.The customer sent samples to another laboratory for testing.Of the data provided for four patient samples, only the results for one patient were discrepant.The initial chloride result was 106 mmol/l and the repeat result was 96 mmol/l.The initial result was reported outside the laboratory.The repeat result was believed to be correct.The patient was not adversely affected.The electrode lot number and expiration date were requested but were not provided.The field service representative found a problem with the vacuum/ pressure and the mix /dry line from the pump was kinked and restricting flow.He replaced the tubing to the air pump, rerouted the lines, and wrapped them in place.He performed mix/dry adjustments to specification and the customer successfully ran calibration and controls with results near the mean values.

Manufacturer Narrative

Clarification was provided that the customer runs the ise direct method.Based on this, an incorrect mixing pressure as found by the field service representative would not have cause the event.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Possible causes include an issue with the sample itself or a preanalytical problem.No information was provided that reasonably suggests a systemic problem with the device.

• Brand Name: COBAS INTEGRA 400 PLUS
• Type of Device: CLINICAL CHEMISTRY 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: 6629159
• MDR Text Key: 77446559
• Report Number: 1823260-2017-01184
• Device Sequence Number: 0
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 05/24/2017
• Supplement Dates FDA Received: 07/07/2017
• 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: 4 YR