MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 IGF-1 (RE-STANDARDIZED)

Model Number	IMMULITE 2000 IGF-1 (RE-STANDARDIZED
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer informed siemens that additional patient information and system files are not available.The customer informs that there is no malfunction with the immulite 2000 xpi system and that all maintenance is performed.The customer has stated that the low bias can be explained by the restandardization of the ifg-1 assay and their mistake of not informing the physician(s) about the immulite 2000 igf-i restandardization (customer bulletin # 11222908, rev.A, 2016-05) and the expected decrease in patient results.The cause of the event is use error.
Event or Problem Description
The customer informed siemens that patient samples were run daily for insulin-like growth factor-1 (igf-1) on an immulite 2000 xpi instrument and a non-siemens instrument.Both results were reported to the physician(s), who questioned the discordant immulite 2000 xpi results.The physician(s) observed that lower results were obtained on the immulite 2000 xpi instrument when compared to the non-siemens method.There are no known reports of patient intervention or adverse health consequences due to the difference in igf-1 patient results.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00116 was filed on 22-mar-2018.Correction (26-march-2018): section lot # should only list "109".Section report source should include "user facility" not "company representative".Additional information: the kit lot numbers that are associated with this event are: 109, 110, 111, 114, 116, 117, 119, 120, 121, 123.Separate mdrs were filed for the igf-1 kit lots 109, 110, 111, 114, 116, 117, 119, 120, 121, 123.The following mdrs are associated to this customer and event: 2432235-2018-00116, 2432235-2018-00118, 2432235-2018-00119, 2432235-2018-00120, 2432235-2018-00121, 2432235-2018-00122, 2432235-2018-00123, 2432235-2018-00124, 2432235-2018-00125, 2432235-2018-00126.

• Brand Name: IMMULITE 2000 IGF-1 (RE-STANDARDIZED)
• Common Device Name: IMMULITE 2000 IGF-1 (RE-STANDARDIZED)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7364105
• Report Number: 2432235-2018-00116
• Device Sequence Number: 10789756
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: 00630414601236
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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 2000 IGF-1 (RE-STANDARDIZED
• Device Catalogue Number: L2KIGF2
• Device Lot Number: 109, 110, 111, 114, 116, 117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1