MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE INTACT PTH CONTROL MODULE

Model Number	IMMULITE INTACT PTH CONTROL MODULE
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer notifications imc17-22.A.Us and imc17-22.A.Ous were sent out in (b)(6) 2017 to all us and ous customers who received the affected in-date lots of immultie intact pth control module lots 059 and 060/060l and are users of the immulite turbo intact pth assay, to notify them of a possible failure to meet the published ranges in the ifu.The customers were informed that the kit can be used if quality control is within published ranges.If quality control is outside of published range the customer may ask for replacement control module kits.Ultimately, based on the investigation results, this issue was determined to be a negligible health risk.Mdr 2432235-2016-00757 was filed for the same event.
Event or Problem Description
The customer reported that their quality control was out of range when running turbo intact parathyroid hormone (turbo ipth) assay on an immulite 1000 instrument, when using reagent lot 241 and quality control kit lot 060.The intra operative surgeries for seven patients were delayed as the sample testing could not be performed due to quality control being out of range.There are no known reports of adverse health consequences due to rescheduling of the surgeries.

• Brand Name: IMMULITE INTACT PTH CONTROL MODULE
• Common Device Name: IMMULITE INTACT PTH CONTROL MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 6851220
• Report Number: 2432235-2017-00507
• Device Sequence Number: 489240
• Product Code: CEW
• UDI-Device Identifier: 00630414953236
• UDI-Public: 00630414953236
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K013566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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
• Operator of Device: Health Professional
• Device Model Number: IMMULITE INTACT PTH CONTROL MODULE
• Device Catalogue Number: LPHCM
• Device Lot Number: 060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1