MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 CYTOMEGALOVIRUS IGG

Model Number IMMULITE 2000 CYTOMEGALOVIRUS IGG

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2015

Event Type  malfunction  

Event Description

A discordant, false positive result was obtained on one patient sample for cytomegalovirus igg (cmv igg) on an immulite 2000 xpi instrument while using reagent lot 298.The discordant, false positive result was reported to the physician(s), who questioned it.A sample obtained from the patient prior had resulted negative on an alternate platform.A new sample was drawn from the patient and tested on the same instrument, also resulting positive.The new sample was then repeated on two alternate platforms, both resulting negative.The patient had a history of testing positive on immulite instrument.The corrected results from the alternate platforms were not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the false positive cmv igg results.

Manufacturer Narrative

The cause for the false positive cytomegalovirus igg result is unknown.Siemens healthcare diagnostics is investigating the issue.

Manufacturer Narrative

The initial mdr 2432235-2015-0099 was filed on february 26, 2015 additional information (02/23/2015): siemens requested the sample material from the customer for further investigation, but it was not provided.A siemens headquarters support center (hsc) specialist reviewed the patient data and could not determine the cause of the interference.The customer did not report any more discordant results.The cause of discordant, falsely positive result for cytomegalovirus igg (cmv igg) on one patient sample is unknown.

• Brand Name: IMMULITE 2000 CYTOMEGALOVIRUS IGG
• Type of Device: IMMULITE 2000 CYTOMEGALOVIRUS IGG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; glyn rhonwy; llanberis, caernarfon; gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944); glyn rhonwy; llanberis, caernarfon; gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer Contact: elizabeth beato ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243074
• MDR Report Key: 4551556
• MDR Text Key: 16989021
• Report Number: 2432235-2015-00099
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K993952
• 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
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 CYTOMEGALOVIRUS IGG
• Device Catalogue Number: L2KCVG
• Device Lot Number: 298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1