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

Model Number I400+

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of an erroneous low result for 1 patient sample tested for bilt2 bilirubin total dpd gen.2 (bilt2) on a cobas integra 400 plus (i400+).It is not known if the erroneous result was reported outside of the laboratory.The initial bilt2 result was 0.01 mg/dl.Repeat testing was performed on another i400+ analyzer with a bilt2 result of 1.21 mg/dl.The bilt2 reagent lot and expiration date were requested but not provided.There was no allegation of an adverse event.The customer stated that they have already detected what they believe the problem to be.They believed the sample was at fault because after the initial discrepant result they performed maintenance and measured qc and no other problems were observed.

Manufacturer Narrative

There have been no further incidents reported.A definitive root cause could not be determined.

Manufacturer Narrative

A field service engineer performed several service activities including cleaning of the cuvette rotors, the washing station, photometer lenses, workstations, probes, and the water reservoir.He adjusted the belt tension.There have been no further discrepant results following the service visit.

• 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: 7002589
• MDR Text Key: 92180399
• Report Number: 1823260-2017-02536
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2018

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: 03245233001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 10/18/2017; 10/18/2017
• Supplement Dates FDA Received: 03/05/2018; 03/27/2018
• 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