MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM); ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 04784618190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The sales representative indicated that the customer complained of erroneous results for 1 pregnant patient tested for igm antibodies to cytomegalovirus (cmv igm) and igg antibodies to cytomegalovirus (cmv igg).The date of event was not known.The erroneous results were reported outside of the laboratory.This medwatch will cover cmv igm.Refer to medwatch with (b)(6) for information on the cmv igg erroneous results.The initial cmv igm and cmv igg results from the e602 analyzer were negative.The actual results were not provided.The physician did not believe these results.The sample was sent to an external laboratory using the abbott method and the cmv igm and cmv igg results were positive.The actual results were not provided.No adverse event occurred.The e602 analyzer serial number was (b)(4).The customer provided additional cmv igm and igg results from (b)(6) 2016.The customer believes that these results show that seroconversion was not detectable on the e602 analyzer.

Manufacturer Narrative

A specific root cause could not be identified.Additional information was requested for investigation but was not provided.The customer submitted a sample from 06/14/2016 and the discrepant results were from a sample from 06/23/2016.The sample from 06/23/2016 was not available for investigation.The sample from 06/14/2016 was tested.The sample produced positive results for the elecsys cmv igm assay, the recomline cmv igm assay, the elecsys cmv igg assay and the recomline cmv igg assay.The elecsys cmv igg avidity results were low.The data indicate the patient had been recently infected with cmv.The sample from 06/14/2016 produced results that were comparable to the competitor system.

• Brand Name: IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: 5794810
• MDR Text Key: 49636833
• Report Number: 1823260-2016-00924
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04784618190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• 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