MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGG ANTIBODIES TO CYTOMEGALOVIRUS; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 04784596190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

The customer complained of an issue with the detection of a cmv infection for 1 patient.The patient was tested for igg antibodies to cytomegalovirus (cmv igg) on 4 different occasions.Of the data provided, the samples from 2 of the 4 occasions were false negative.It is not known if the erroneous results were reported outside of the laboratory.This information has been requested.On (b)(6) 2015 the initial cmv igg result was <0.5 u/ml (negative).The repeat result from an architect analyzer was 11.2 (unit of measure not provided).On (b)(6) 2015 the initial cmv igg result was <0.5 u/ml (negative).The repeat result from an architect analyzer was 23 (unit of measure not provided).No adverse event occurred.The e601 analyzer serial number was not provided.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Clarification has been received that the erroneous results were reported outside of the laboratory.An amniocentesis was performed based on the roche result, however, the patient was not adversely affected.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The patient samples were submitted for investigation.The customer's results were reproduced during the investigation.Weak (b)(6) were detected in the samples that produced the results from (b)(6) 2015 and (b)(6) 2015 resulting in a borderline test result using the recomline cmv assay.These results are mostly triggered by a reaction towards the p65 antigen.(b)(6) has known cross-reactivity to other members of (b)(6) and is not included in the roche cmv igg assay.Due to this, the rare case that an early phase igg antigen response that is exclusively reactive to the p65 antigen can be overlooked as happened for this patient.The investigation for the samples from (b)(6) 2015 and (b)(6) 2015 determined the (b)(6) samples had low avidity.

• Brand Name: IGG ANTIBODIES TO CYTOMEGALOVIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4872123
• MDR Text Key: 6048043
• Report Number: 1823260-2015-03731
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K131605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04784596190
• Device Lot Number: 178607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/05/2015
• 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