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

Catalog Number 03183688122

Device Problem High Test Results (2457)

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

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for alb2 albumin gen.2 (alb) on two cobas 6000 c (501) module - c501 analyzers.An erroneous result was reported outside of the laboratory to the patient and the physician.The sample initially resulted as 37.1 g/l.The sample was repeated on a second c501 analyzer, resulting as 37.4 g/l.The sample was repeated on an abbott architect analyzer, resulting as 26.4 g/l.The physician indicated that the low result obtained with the architect analyzer was more in line with the medical state of the patient and the electrophoresis results of the patient.No adverse events were alleged to have occurred with the patient.The serial numbers of the c501 analyzers were asked for, but not provided.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.It was assumed that blood proteins related to gammopathy were present in the sample and interfered with the alb assay.As no sample was available, further investigations were not possible.

• 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: 6973170
• MDR Text Key: 90874986
• Report Number: 1823260-2017-02410
• Device Sequence Number: 1
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 03183688122
• Device Lot Number: 267122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/24/2017
• 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: 43 YR