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

Model Number IMMULITE 2000 FSH

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

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

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, falsely elevated fsh results on one patient sample is unknown.Siemens is investigating the issue.

Event Description

The customer obtained discordant, falsely elevated follicular stimulating hormone (fsh) results on one patient sample upon initial and repeat testing on an immulite 2000 xpi instrument, when using reagent lot 326.The discordant results were reported to the physician(s), who questioned them.The sample was repeated on two alternate platforms, resulting lower each time and matching the clinical picture of the patient.The corrected result obtained on the 2nd alternate platform was reported to the physician(s).There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely elevated fsh result.

• Brand Name: IMMULITE 2000 FSH
• Type of Device: IMMULITE 2000 FSH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6311756
• MDR Text Key: 67268684
• Report Number: 2432235-2017-00085
• Device Sequence Number: 1
• Product Code: CGJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 FSH
• Device Catalogue Number: L2KFS2
• Device Lot Number: 326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR