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

Catalog Number 03183688122

Device Problem Low Test Results (2458)

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

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for two patient samples tested for alb2 albumin gen.2 (alb) on two cobas 6000 c (501) module - c501 analyzers.The erroneous results were reported outside of the laboratory.The patient samples were collected intravenously and not from a cannula connected to these dialysis patients.There was no problem with all other tests run on the samples.The first sample was tested twice on the customer's c501 analyzer and resulted as 0.20 g/dl accompanied by a data flag.The sample was repeated on a c501 analyzer from another laboratory and resulted with a value that was less than the measuring range of the assay and was accompanied by a data flag.The sample was repeated twice on a vitros analyzer, resulting as 2.32 g/dl and 2.53 g/dl.The second sample, from a (b)(6) year old male patient, was tested twice on the customer's c501 analyzer on (b)(6) 2017 and resulted as 0.20 g/dl accompanied by a data flag.The sample was repeated on a c501 analyzer from another laboratory and resulted with a value that was less than the measuring range of the assay and was accompanied by a data flag.The sample was repeated on a vitros analyzer, resulting as 2.3 g/dl.No adverse events were alleged to have occurred with the patients.The customer's c501 analyzer serial number was (b)(4).The serial number of the c501 analyzer used at the other laboratory was asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.There was no additional sample volume remaining for further investigation.Additional information required for the investigation was requested, but not provided.Possible root causes relate to the following: -pre-analytic sample handling, -the presence of an interferent in the sample (gammopathy or unknown interferent) , causing interference with the roche assay , -foam/bubbles on the sample surface, -no pipetting of reagent, -electrical discharge in the sample probe due to < 30% humidity within the laboratory, -misalignment of the sample cup/tube due to sample probe mis-adjustment.-non use of rack adapters for sample cups.The vitros assay may yield a different result due to different methodology.Upon review of the alarm trace, an abnormal sample aspiration alarm was observed on the date of the event.A drug interference with the roche assay is not likely.

• 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: 6597943
• MDR Text Key: 76391719
• Report Number: 1823260-2017-01106
• Device Sequence Number: 1
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03183688122
• Device Lot Number: 214793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• 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: 56 YR