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

Model Number IMMULITE 2000 IGF-1 (RE-STANDARDIZED)

Device Problem Human Factors Issue (2948)

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

Event Date 11/01/2016

Event Type  malfunction  

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.Separate mdrs were filed for the ifg-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, 2432235-2018-00122, 2432235-2018-00123, 2432235-2018-00124, 2432235-2018-00125, 2432235-2018-00126.

Event 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.

• Brand Name: IMMULITE 2000 IGF-1 (RE-STANDARDIZED)
• Type of Device: IMMULITE 2000 IGF-1 (RE-STANDARDIZED)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7367618
• MDR Text Key: 103791829
• Report Number: 2432235-2018-00121
• Device Sequence Number: 1
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: 00630414601236
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 IGF-1 (RE-STANDARDIZED)
• Device Catalogue Number: L2KIGF2
• Device Lot Number: 116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• 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: Reuse
• Patient Sequence Number: 1