MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED IMMULITE/IMMULITE 1000 CORTISOL

Model Number IMMULITE/IMMULITE 1000 CORTISOL

Device Problem High Test Results (2457)

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

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The customer has observed high bias results on two levels for biorad quality control samples when using the cortisol assay reagent lot 382 on an immulite 1000 system.The bias was also observed by the customer for reagent lots 378 and 379.The customer did not report any patient sample data.There are no known reports of patient intervention or adverse health consequences due to the high bias observed on the biorad quality control samples.

Manufacturer Narrative

Siemens has confirmed that immulite/immulite 1000 cortisol kit lots 381, 382, and 383 demonstrate a positive bias with patient samples in the range of approximately 13% to 40%.The positive bias was also observed in quality control materials and may result in values outside the established ranges.The issue has been resolved with immulite/immulite 1000 cortisol kit lots (b)(4) and above.An urgent medical device recall umdr2014-09-19 was sent to us customers and an urgent field safety notice (ufsn) 1111, was sent to ous customers in september of 2014.The umdr and ufsn state that customers are requested to discontinue use of and discard the immulite/immulite 1000 cortisol kits listed, and to review the umdr/ufsn with their medical director.

• Brand Name: IMMULITE/IMMULITE 1000 CORTISOL
• Type of Device: IMMULITE/IMMULITE 1000 CORTISOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; 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: 4111371
• MDR Text Key: 4717025
• Report Number: 2432235-2014-00551
• Device Sequence Number: 1
• Product Code: CGR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K931409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: IMMULITE/IMMULITE 1000 CORTISOL
• Device Catalogue Number: LKCO
• Device Lot Number: 382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• 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: 2432235-09/22/14-003R
• Patient Sequence Number: 1