MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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 07/03/2013

Event Type  malfunction  

Event Description

The customer has obtained falsely high values on five patient samples for the androstenedione assay on an immulite 2000 instrument, when using reagent lot 315.The five patient samples were also run on an alternate platform where the results were lower.The last sample was retested on the immulite 2000 instrument using a heterophile blocking tube (hbt).The patient results from the immulite 2000 instrument were not released to the physician(s).It is unknown if the results from the alternate platform were released to the physician(s).There were no known reports of patient intervention or adverse health consequences due to the falsely high values obtained on the five patient samples when using reagent lot 315.

Manufacturer Narrative

Siemens has investigated the incidence of over recovery of patient samples and quality controls on the immulite/immulite1000 androstenedione assay lot number 409 and above, and immulite 2000/immulite 2000 xpi androstenedione assay lot number 314 and above.Siemens has confirmed that these lots are linear up to a concentration of 5.5 ng/ml, instead of the 10 ng/ml as stated in the instructions for use (ifu).Quality control materials at concentrations between 5.5 ng/ml and 10 ng/ml will detect this issue.An urgent medical device correction (umdc) 2013-12-19 was sent to us customers and an urgent field safety notice (ufsn) 4008 was sent to (b)(4) customers in december of 2013.The (b)(4) that customers are requested to use quality control materials with at least two levels having concentrations less than 5.5 ng/ml, and that patient values >5.5 ng/ml should be verified using an alternate method.

Manufacturer Narrative

The original mdr 2432235-2014-00032 was filed on january 8, 2014.Additional information (5/27/14): the over recovery and loss of linearity of the immulite systems androstenedione assay has been identified to be variability of a critical raw material (variation in the activity of rma160 alkaline phosphatase (unlabeled/low activity alkaline phosphatase, cold ap) in the reagent wedge).In addition, siemens healthcare sent out a customer bulletin 2014-05 in may 2014, announcing the restoration of the linearity of the androstenedione assay on the immulite 2000/immulite 2000 xpi to 10 ng/ml (35 nml/l), beginning with kit lot 331.

• Brand Name: IMMULITE 2000 ANDROSTENEDIONE
• Type of Device: IMMULITE 2000 ANDROSTENEDIONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; glyn rhonwy; llanberis, caernarfon, gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS(REG#3002806944); glyn rhowny; llanberis, caernarfon; gwynedd, wales LL5 4EL; UK LL5 4EL
• Manufacturer Contact: elizabeth beato ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243074
• MDR Report Key: 3562244
• MDR Text Key: 16448321
• Report Number: 2432235-2014-00032
• Device Sequence Number: 1
• Product Code: CIZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• 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: 315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2014
• 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: 2432235-01/02/14-001-C
• Patient Sequence Number: 1