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

Model Number IMMULITE 2000 RUBELLA IGM

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed the rubella igm reagent lots d236m, d238, 236m, 237, 238, 239, and 239l on the immulite 2000/immulite 2000 xpi systems and reagent lots 333, and 334 on the immulite/immulite 1000 systems exhibit increased imprecision on patient samples.Siemens internal investigation demonstrate that some patient samples exhibit higher percent coefficient of variation (%cv) than the precision performance published in the instructions for use (ifu) for this assay.Quality controls provided in the rubella igm kit may not detect the imprecision with patient results.An urgent field safety notice (ufsn) (b)(4) was sent to ous customers and a urgent medical device recall (umdr) (b)(4) was sent to us customers in august of 2016.The ufsn and umdr state that customers are to discontinue and discard the kits lots affected, and to request a replacement lot.Siemens recommends transitioning to immulite/1000 rubella igm kit lot 0337 and above or to immulite 2000/2000 xpi rubella igm kit lot 240 and above.

Event Description

The customer has indicated that they are obtaining an increase in positive and indeterminate results for rubella igm assay on the immulite 2000 instrument when using kit lot 238.The samples were repeated on an alternate platform and the results were negative.Results on four patient samples was provided by the customer.It is unknown if any of the results were provided to the physician(s).There were no reports of patient intervention or adverse health consequences due to the increase in positive and indeterminate results for the rubella igm assay.

• Brand Name: IMMULITE 2000 RUBELLA IGM
• Type of Device: IMMULITE 2000 RUBELLA IGM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; glyn rhowny; llanberis, caernarfon; gwynedd, wales, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; glyn rhowny, llanberis; gwyness, caernarfon; wales, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5924718
• MDR Text Key: 53817001
• Report Number: 2432235-2016-00441
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 RUBELLA IGM
• Device Catalogue Number: L2KRM
• Device Lot Number: 238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/02/2016
• 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
• Removal/Correction Number: 2432235-08/25/2016-002-R
• Patient Sequence Number: 1