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

Catalog Number 04784596190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they have received an erroneous high result for one patient sample tested for the elecsys (b)(6) on a cobas 6000 e 601 module (e601).The erroneous result was reported outside of the laboratory.A first sample from the patient was tested on an e601 in the customer's laboratory on (b)(6) 2015 and resulted as 5.7 u/ml ((b)(6)) for (b)(6).The result was obtained during the patient's first pregnancy and was not questioned.A second sample from the patient was tested in a second laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as 0.4 au/ml ((b)(6)) for (b)(6).A third sample from the patient was tested on the customer's e601 analyzer (serial number (b)(4)) on (b)(6) 2016 and the result was 27 u/ml ((b)(6)) for (b)(6).This sample was repeated at a third laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as (b)(6) for (b)(6).The customer does not know if the patient is (b)(6) for (b)(6).The patient was not adversely affected.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations were able to duplicate the results of the customer.The sample showed clear reactivity with the roche cmvigg assay.There was no evidence for systemic interference of the sample with the general assay components.Antigen specific interference also appeared to be unlikely.The presence of cmv specific igg antibodies is supported by the recomline cmv igg assay, however, the detected signals are below the assay's cutoff (borderline result).The cmv specific igg antibodies were determined to be of high avidity (101%).This suggests that the patient had been remotely infected with cmv and has already acquired specific immunity.The root cause of the observed discrepancy between the roche cmvigg assay and the abbott assay could not be determined.Further testing of the patient with other independent methods, together with information on the clinical history of the patient may help to refine the diagnostic cmv status.

• Brand Name: CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS
• 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: 6300774
• MDR Text Key: 66507244
• Report Number: 1823260-2017-00213
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 04784596190
• Device Lot Number: 174473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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
• Patient Age: 39 YR