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 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that their quality controls were within acceptable range.The cause of the discordant, falsely low fsh results on one patient sample is unknown.Siemens is investigating the issue.

Event Description

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

Manufacturer Narrative

The initial mdr 2432235-2017-00226 was filed on april 12, 2017.Additional information (04/27/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer.It was unknown what medications were taken by the patient.The hsc specialist stated that there was no device issue.The hsc specialist also stated that as the discordant results were reproducible on the immulite 2000 xpi instrument only affecting one patient sample, it rules out any mechanical issue.Siemens is unable to perform in-house testing as the patient sample is not available for further evaluation.The cause of the discordant, falsely low fsh results on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.

• Brand Name: IMMULITE 2000 FSH
• Type of Device: IMMULITE 2000 FSH
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk 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: 6484846
• MDR Text Key: 72499176
• Report Number: 2432235-2017-00226
• 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,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• 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 Lot Number: 326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 30 YR