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

Model Number IMMULITE 2000 ANDROSTENEDIONE

Device Problems Nonstandard Device (1420); High Test Results (2457)

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

Event Date 02/19/2014

Event Type  malfunction  

Event Description

The customer is concerned with the imprecision observed on patient samples for the androstenedione assay on an immulite 2000 instrument when using reagent lot 318.High imprecision was observed on samples <5.5 ng/ml.Five samples were run as part of an imprecision study on an immulite 2000 instrument and five different samples were run on another immulite 2000 instrument.It is unknown if patient sample results were reported to the physician(s).There were no known reports of patient intervention or adverse health consequences due to the imprecision observed on the patient samples for the androstenedione assay.

Manufacturer Narrative

Siemens has observed over-recovery in the immulite/immulite 1000/immulite 2000 androstenedione assay for samples across the assays' reportable range of 0.3-10 ng/ml (1.1-35 nmol/l).Siemens has confirmed that the issue noted in the december 2013 field action is not limited to only samples >5.5 ng/ml (19.2 nmol/l).Siemens has identified that the root cause of the over-recovery is related to the variability of a critical raw material.This issue has been resolved beginning with immulite/immulite 1000 kit lot 431, and for immulite 2000 beginning with kit lot 331.An urgent field safety notice (ufsn) 1113 for immulite/immulite 1000 and ufsn 3021 for immulite 2000 was sent to ous customers in november of 2014.The ufsn recommends that the customer discard the affected kit lots and to review the letter with their medical director.

• Brand Name: IMMULITE 2000 ANDROSTENEDIONE
• Type of Device: IMMULITE 2000 ANDROSTENEDIONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; registration # 3002806944; glyn rhonwy; llanberis, caernarfon, gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; registration # 3002806944; glyn rhonwy; llanberis, caernarfon, gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer Contact: elizabeth beato ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243074
• MDR Report Key: 4294752
• MDR Text Key: 5272696
• Report Number: 2432235-2014-00672
• Device Sequence Number: 1
• Product Code: CIZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: IMMULITE 2000 ANDROSTENEDIONE
• Device Catalogue Number: L2KAO
• Device Lot Number: 318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2014
• 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: Initial
• Removal/Correction Number: 2432235-11/20/14-005R
• Patient Sequence Number: 1