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

Model Number IMMULITE 2000 HUMAN CHORIONIC GONADOTROPIN

Device Problem Low Test Results (2458)

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

Event Date 12/21/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report that discordant, falsely depressed total human chorionic gonadotropin (hcg) results were obtained for a single patient sample on an immulite 2000 xpi instrument.Customer stated that quality control was not tested the day the discordant results were obtained.Additionally, the patient sample that generated the discordant results is no longer available for additional troubleshooting.The customer has monitored hcg performance since the day of the discordant results and there have been no further concerns.This issue appears to be isolated to a single patient sample.A systemic product non-conformance was not identified.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.The cause of the discordant, falsely depressed hcg results is unknown.The instrument is performing according to specifications.No further evaluation is required.

Event Description

The customer contacted the siemens customer care center (ccc) to report that discordant, falsely depressed total human chorionic gonadotropin (hcg) results were obtained for a single patient sample on an immulite 2000 xpi instrument.The initial discordant result was reported to the physician(s) and questioned.The customer repeated the same sample on the same instrument, resulting lower and not as expected.It is unknown if the repeat result was reported to the physician(s).Quality control was not tested on the day of the discordant results.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed hcg results.

• Brand Name: IMMULITE 2000 HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
• Type of Device: HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: mir khan ; 511 benedict avenue; tarrytown, ny ; 5243074
• MDR Report Key: 9775860
• MDR Text Key: 193001179
• Report Number: 2432235-2020-00221
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: IMMULITE 2000 HUMAN CHORIONIC GONADOTROPIN
• Device Catalogue Number: 10381206
• Device Lot Number: 402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1