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

Catalog Number 05166861190

Device Problem Low Test Results (2458)

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

Event Date 10/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable low alb2 albumin gen.2 results for qc material and up to 10 patient samples.The samples were repeated on another analyzer at the site.Of the data provided for two patient samples, only the results for one patient sample were discrepant.The initial result was 2.3 g/dl and the repeat result was 2.9 g/dl.The erroneous results were reported outside of the laboratory.The repeat results were believed to be correct and corrected reports were sent.The customer did not have any information regarding an adverse event.There was no allegation of an adverse event.The customer replaced the reagent pack and qc recovery was then in range.They repeated testing and obtained results comparable to results on other analyzer.The field service representative could not find a cause.Calibration and qc results passed.The customer used cobas 8000 c 702 module serial number (b)(4).

Manufacturer Narrative

A specific root cause could not be identified.Based on the data provided, a general reagent, calibration, or hardware issue was excluded.An issue with the individual reagent cassette was likely the cause as no other complaints for this lot of reagent have been received and the use of another cassette solved the issue.

• Brand Name: 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: 6989822
• MDR Text Key: 91211710
• Report Number: 1823260-2017-02471
• Device Sequence Number: 1
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033009
• 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: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 05166861190
• Device Lot Number: 24935901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2017
• 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