MAUDE Adverse Event Report: ROCHE DIAGNOSTICS VITAMIN B12; RADIOASSAY, VITAMIN B12

Catalog Number 04745736190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/31/2014

Event Type  malfunction  

Event Description

The customer alleged they received questionable vitamin b12 results on their e601 analyzer.The customer alleged they received a shift in their quality control results and a very big shift in results on patient samples when they used a new lot of reagent.The customer repeated the patient samples on (b)(6) 2014 and obtained values much lower than the initial results.The customer provided results for 50 patients, three of which had discrepant results.The first patient's initial vitamin b12 result was 422.5 pg/ml.The repeat result was 275.1 pg/ml.The second patient's initial vitamin b12 result was 431.2 pg/ml.The repeat result was 281.9 pg/ml.The third patient's initial vitamin b12 result was 185.1 pg/ml.The repeat result was 107.1 pg/ml accompanied by a data flag.Information on whether the discrepant results were reported outside the laboratory was requested but not provided.There were no deaths, injuries, illnesses, or deteriorations in health associated with the erroneous results.Information on whether the patient was harmed by any action taken was requested but not provided.The vitamin b12 reagent lot number was 175380.The expiration date was requested but not provided.

Manufacturer Narrative

It was determined the differences in the patient results seen by the customer were related to a known issue covered in a product bulletin.Roche has confirmed that the elecsys vitamin b12 reagent, lot numbers 172593 and 174159 recover slightly higher than previous lots but still within the specified range.As a result, the newest lot of vitamin b12, 175380, was adjusted to recover lower, similar to lots made prior to lot number 172593.There is no risk associated with any currently available lots of vitamin b12, as they all perform within product release specifications.Recovery with native patient samples was within specification.(b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: VITAMIN B12
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3763507
• MDR Text Key: 4418902
• Report Number: 1823260-2014-02923
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745736190
• Device Lot Number: 175380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/01/2014
• 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
• Patient Sequence Number: 1