MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 HCG; IMMULITE 2000 XPI - HUMAN CHORIONIC GONADOTROPIN (HCG)

Model Number	IMMULITE 2000 - HCG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.A customer service engineer (cse) was dispatched to the customer site.The cse performed an inspection of the instrument, replaced the sample and reagent probes as a proactive measure.The cse ran the water test and the quality control (qc) which were both found within ranges.The instrument is performing within specification.Siemens is investigating the issue.Mdr 2432235-2020-00192 was filed for the same event.
Event or Problem Description
Two discordant, falsely depressed human chorionic gonadotropin (hcg) results were obtained using immulite 2000 xpi.The discordant results were not reported to the physician(s).Two repeat results were performed using alternate immulite 2000 xpi and were considered correct.One of the correct results was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed hcg result.
Additional Manufacturer Narrative
The initial mdr 2432235-2020-00191 was filed on 24-feb-2020.Additional information (24-feb-2020): siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc found that there is insufficient information to determine the cause of the false reactive result.Hsc cannot rule out pre-analytical factors or sample issue.Hsc did not identify a product problem.The instrument is performing within specification.No further evaluation of the device is required.Section(s) h6 and h10 were updated to reflect the additional information.Mdr 2432235-2020-00192-s1 was filed for the same event.

• Brand Name: IMMULITE 2000 HCG
• Common Device Name: IMMULITE 2000 XPI - HUMAN CHORIONIC GONADOTROPIN (HCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9748506
• Report Number: 2432235-2020-00191
• Device Sequence Number: 1767110
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: 00630414961149
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990222
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 05/31/2020
• Device Model Number: IMMULITE 2000 - HCG
• Device Catalogue Number: 10381194
• Device Lot Number: 451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1