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 Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/13/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, falsely low igf-1 (re-standardized) result on one patient sample is unknown.Siemens is investigating the issue.

Event Description

The customer obtained a discordant, falsely low insulin-like growth factor i (re-standardized) on one patient sample on an immulite 2000 xpi instrument, when using reagent kit lot 113.A new sample was obtained from the patient and was tested on an alternate immulite 2000 xpi instrument using an igf-1 method, resulting higher.The original sample was then tested on an alternate immulite 2000 xpi instrument using an igf-1 method, also resulting higher.It is unknown if the initial result was reported to the physician(s).The higher results obtained using igf-1 method were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low igf-1 (re-standardized) result.

Manufacturer Narrative

The initial mdr was filed on june 8, 2017.Additional information (08/06/2017): a siemens headquarters support center specialist reviewed the event data and concluded that the differences in assay standardization can cause results to differ.L2kigf is standardized to who nibsc 1st is 02/254.As per the immulite 2000 xpi insulin-like growth factor i (re-standardized) instructions for use, reference range data is what was observed with the population of sample tested by siemens and limits should be considered as guidelines only.Each laboratory should establish its own reference ranges.For diagnostic purposes, the results obtained from the assay should always be used in combination with the clinical examination, patient medical history, and other findings.The device is performing within manufacturing specifications.No further evaluation of device is required.Mdrs 2432235-2017-00353 and 2432235-2017-00358 were filed for the same event.

• 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; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6622338
• MDR Text Key: 77450908
• Report Number: 2432235-2017-00359
• Device Sequence Number: 1
• Product Code: CFL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 49 YR