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

Model Number IMMULITE 2000 CYTOMEGALOVIRUS IGG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the event data.The sample was not available for in-house testing.The review of internal kit release between kit lots 326, 327 and 328 did not show any samples that were clinically non-concordant.The hsc specialist could not be determine if the cause of the issue was due to sample precision or a potential non-specific interference.The customer reported indeterminate result as a correct result for the sample in question.As per immulite 2000 xpi cmv igg instructions for use, "any result of indeterminate (ratio between 0.9 and less than 1.1) should be retested.Samples which still test as indeterminate should be tested by an alternate method, or a second sample should be taken - if possible - within a reasonable period of time (e.G., one week).The presence of igg antibodies to cmv is an indication of previous exposure to the virus.A single specimen can only be used to determine the serological status of the individual." the cause of an indeterminate result being reported to the physician(s) was failure to follow instructions.The device is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

A discordant, (b)(6) result for igg antibodies to (b)(6) assay was obtained on one patient sample on an immulite 2000 xpi instrument, while using kit lot 328.The (b)(6) result was not reported to the physician(s).The sample was initially run using kit lots 326 and 327, resulting indeterminate and (b)(6) respectively.The customer reported an indeterminate result from kit lot 326 and considered it to be correct.The (b)(6) result obtained using kit lot 327 was not reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant (b)(6) result.

• 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: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 7349099
• MDR Text Key: 103290001
• Report Number: 2432235-2018-00108
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 00630414961231
• UDI-Public: 00630414961231
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K993952
• 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
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• 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: L2KCVG2
• Device Lot Number: 328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• 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