MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALB2 ALBUMIN GEN.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Model Number C501

Device Problem Low Test Results (2458)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).(b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for alb2 albumin gen.2 (alb) on a cobas 6000 c (501) module - c501.The erroneous result was reported outside of the laboratory and questioned by the clinicians.The sample initially resulted as < 10 and repeated with a result that was twice as high.The units of measured used for the alb assay were asked for, but not provided.No adverse events were alleged to have occurred with the patient.The alb reagent lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

As the sample had high igm, it could not be excluded that a monoclonal gammopathy is the root cause for the customer's issue.According to product labeling, igm gammopathy may cause unreliable results.Additional information required for the investigation was requested, but not provided.The following medwatch fields have been updated.

• Brand Name: ALB2 ALBUMIN GEN.2
• Type of Device: BROMCRESOL GREEN DYE-BINDING, ALBUMIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6950879
• MDR Text Key: 90461921
• Report Number: 1823260-2017-02312
• Device Sequence Number: 2
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K033009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 03183688122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• 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