MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 SYPHILIS SCREEN

Model Number IMMULITE 2000 SYPHILIS SCREEN

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

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

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center specialist reviewed the instrument data and did not find any level sense issues or bubbles.The cause of the (b)(6) result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

A discordant, (b)(6) result was obtained on one patient sample on an immulite 2000 xpi instrument, while using kit lot 312.The discordant result was not reported to the physician(s).The sample was repeated neat and with dilution factor 1:2, resulting reactive both times.The sample was also tested using other methodologies, resulting reactive.The reactive results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, (b)(6) result.

Manufacturer Narrative

The initial mdr 2432235-2018-00045 was filed on 06-feb-2018.Additional information (15-feb-2018): a siemens headquarters support center (hsc) specialist reviewed the event data and indicated that the discordant result was non-reproducible.The review of instrument data did not show any issues that could contribute to the non-reproducible discordant result.The immulite 2000 syphilis instructions for use states "diagnosis of syphilis should not be established on the basis of a single test result, but should be determined in conjunction with clinical findings and other diagnostic procedures, as well as in association with medical judgment.Therefore a precise diagnosis should take into consideration clinical history, symptomatology and serological testing." based on the event information, the hsc specialist concluded that the potential cause of the issue was sample specific.Pre-analytic variables can affect the quality of the sample, and deviation from recommended practices can lead to erroneous results.The cause of the discordant, non-reactive syphilis result on one patient sample is unknown.

Manufacturer Narrative

The initial mdr 2432235-2018-00045 was filed on 06-feb-2018.The first supplemental mdr 2432235-2018-00045_s1 was filed on 12-mar-2018.Additional information (02-apr-2018): siemens technical support laboratory (tsl) obtained the sample in question from the customer and performed in-house testing.The sample was tested with immulite 2000 xpi syphilis screen kits (lot 312 and 313).The sample was also tested with advia centaur syphilis reagent (lot 128040).The in-house results obtained on the immulite 2000 xpi and advia centaur xp instruments were reactive for syphilis.The results obtained by the tsl did not confirm the customer's initial observation of a non-reactive syphilis result.The reactive results obtained by the tsl agree with the results obtained by the customer on the alternate methods.Based on the information provided, the siemens headquarters support center specialist could not rule out the sample specific issue, such as pre-analytical factors.The cause of the discordant, false non-reactive syphilis result on one patient sample is unknown.The device is performing within manufacturing specification.No further evaluation of device is required.Method and conclusion codes in section h6 have been updated.

• Brand Name: IMMULITE 2000 SYPHILIS SCREEN
• Type of Device: IMMULITE 2000 SYPHILIS SCREEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 7245053
• MDR Text Key: 99793344
• Report Number: 2432235-2018-00045
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K091361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2018

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 Model Number: IMMULITE 2000 SYPHILIS SCREEN
• Device Catalogue Number: L2KSY2
• Device Lot Number: 312
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/15/2018; 04/02/2018
• Supplement Dates FDA Received: 03/12/2018; 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR