MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HOMOCYSTINE ENZYMATIC ASSAY; HOMOCYSTEINE TEST

Catalog Number 05385415190

Device Problem Low Test Results (2458)

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

Event Date 01/12/2015

Event Type  malfunction  

Event Description

The customer reported receiving lower control values for homocysteine enzymatic assay (hcys) on reagent lot number 69781101 when comparing to a different reagent lot number 60430301.Controls were in range for reagent lot number 60430301.The customer also had concerns about what appears to be patient results for lot 69781101 when comparing to lot 60430301.It is not known when these results were obtained.It is not known if the same samples were used for repeat testing.A clarification has been requested.It is not known if any erroneous results were reported outside of the laboratory.A clarification has been requested.It was asked, but it is not known if any patients were adversely affected.No adverse events were alleged.The c501 analyzer serial number was (b)(4).

Manufacturer Narrative

Additional information received on (b)(6) 2015 indicates date received by manufacturer, should be (b)(6) 2015.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

The customer provided information indicating date of event, should be (b)(6) 2015.The customer indicated that each set of patient results were from the same sample.Erroneous results were reported outside of the laboratory but it is not known which results.It is not known what patients were affected.It is not known if any patients were adversely affected as the customer does not know which results were erroneous.Investigation results determined that the under recovery of edta plasma samples is related to an aging effect of reagent lot 697811 when the lot neared the end of its shelf life.The reagent lot of 697811 had achieved 12 months shelf life.This issue affects edta plasma samples only.Serum is not affected.This issue is related to one bulk of reagent of (b)(4) and only occurs for reagent that has aged >12 months.The key enzyme of the test hmtase (homocysteine s-methyltransferase) is strongly mg++ dependent.As the reagent neared the end of its shelf life, the sample bias became evident with edta samples where mg++ in the reagent was more easily chelated from the enzymes.A field corrective action will be initiated.

• Brand Name: HOMOCYSTINE ENZYMATIC ASSAY
• Type of Device: HOMOCYSTEINE TEST
• 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: 4491621
• MDR Text Key: 5567709
• Report Number: 1823260-2015-00916
• Device Sequence Number: 1
• Product Code: LPS
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K113793
• 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,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05385415190
• Device Lot Number: 69781101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 01/12/2015
• 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