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 Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received a questionable low elecsys cmv igm immunoassay result for one patient.The sample was repeatedly non-reactive and a result of 0.441 coi was reported outside of the laboratory.The sample was then tested for cmv avidity with an abbott method and the result was low avidity (index 3.27).Both the cmv igm and igg results were reactive by the abbott method.No specific results were provided.The sample was then tested by pcr and the viral load was 85000 copies/ml.A second blood draw obtained at a later date also had negative cmv igm results by the roche method.There was no allegation of an adverse event.The customer used a modular e module (evo) analyzer.The serial number was requested but was not provided.

Manufacturer Narrative

As no sample material was available for further investigation, a specific root cause could not be determined.Review of the provided calibration, qc, and analyzer data did not indicate any product problem.

• 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: 6991019
• MDR Text Key: 91924804
• Report Number: 1823260-2017-02493
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• 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: 21691601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• 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