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

Model Number IMMULITE 2000 - HCG

Device Problem Low Test Results (2458)

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

Event Date 01/30/2020

Event Type  malfunction  

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 Description

One discordant, falsely depressed human chorionic gonadotropin (hcg) results was obtained using immulite 2000 xpi.The discordant result was not reported to the physician(s).Three 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.

Manufacturer Narrative

The initial mdr 2432235-2020-00192 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.Mdr 2432235-2020-00191-s1 was filed for the same event.

• Brand Name: IMMULITE 2000 HCG
• Type of Device: 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: 9748504
• MDR Text Key: 204731086
• Report Number: 2432235-2020-00192
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: 00630414961149
• Combination Product (y/n): N
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1