MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - E2

Model Number	IMMULITE 2000 XPI - E2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An urgent medical device correction (umdc) imc20-01.A.Us was sent to us customers and an urgent field safety notice (ufsn) imc20-01.A.Ous was sent to ous customers in february 2020.The umdc and ufsn advise customers of the potential for high discordant estradiol results in some samples on the immulite systems.Siemens healthineers has determined kit lots 501 and above released in july 2018 for the immulite systems are potentially affected.The umdc instructs us customers to discontinue use of and discard estradiol kits currently in their inventory.Customers will also be asked to do a look back if the impacted estradiol kit lots were used to assess the menopausal status of a female while determining therapy for hormone receptor positive advanced or metastatic breast cancer.The ufsn instructs ous customers to review the letter with their medical director to consider if a retrospective review of patient samples is necessary.Customer will also be instructed to not use any current inventory in their laboratory on patient samples used to assess menopausal status while determining therapy for hormone receptor positive advanced or metastatic breast cancer.These samples will need to be tested using an alternate methodology.Customers may continue to use the kits currently in their inventory and report results on other patient populations.Additionally, if a discordant high result for estradiol is suspected, customers are advised to follow their established internal procedures to investigate the issue.
Event or Problem Description
Discordant, falsely elevated estradiol (e2) results were obtained using an immulite 2000 xpi.The initial results were not reported to the physician(s).The repeat results in automated serial dilution of the same sample on the same immulite 2000 xpi were lower.Additional repeat results using an alternate non-siemens method were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated e2 results.

• Brand Name: IMMULITE 2000 XPI - E2
• Common Device Name: IMMULITE 2000 XPI - E2
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9753411
• Report Number: 2432235-2020-00181
• Device Sequence Number: 14096679
• Product Code: CHP
• UDI-Device Identifier: 00630414947907
• UDI-Public: 00630414947907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: IMMULITE 2000 XPI - E2
• Device Catalogue Number: 10702833
• Device Lot Number: 555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-02/10/2020-003-C
• Patient Sequence Number: 1