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

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

Device Problems Labelling, Instructions for Use or Training Problem (1318); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/15/2017

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) result on one patient sample on an immulite 2000 xpi instrument, when using reagent kit lot 116.Different samples were tested earlier using an alternate platform, which had resulted higher on (b)(6) 2016, while the results were similar to that obtained on the immulite 2000 xpi instrument for the other two repeat runs ((b)(6) 2016 and (b)(6) 2017).The result obtained on the immulite 2000 xpi instrument was not reported to the physician(s).The results obtained on the alternate platform 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 2432235-2017-00424 was filed on july 14, 2017.The first supplemental mdr 2432235-2017-00424_s1 was filed on september 13, 2017.Additional information (11/02/2017): the customer contacted a siemens customer care center and stated that they have been testing samples for insulin-like growth factor i (igf-1) on immulite system without further issues.The customer has been using new reference ranges to interpret igf-1 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00424 was filed on july 14, 2017.Additional information (08/25/2017): the treatment for sample id (b)(6) was changed which caused the change in the result.A siemens headquarters support center specialist reviewed the event data and determined that for sample id (b)(6), the insulin-like growth factor i (igf-1) re-standardized result obtained on the immulite 2000 xpi instrument was below the reference range, while it was within the range on an alternate platform.The lms (statistical smoothing method to re-evaluate the original instructions for use data) recalculated igf-1 (re-standardized) reference range for adults in the age group of 45-49 years would be 53.3-215.0 ng/ml.Using this interpretation the sample result would match the result obtained on the alternate platform.Siemens healthcare diagnostics internal investigation has confirmed that immulite systems igf-1 instructions for use reference ranges are inappropriate as statistically calculated in the current instructions for use.Mdrs 2432235-2017-00385 and 2432235-2017-00420 were filed for the same event.

Manufacturer Narrative

(b)(4).Additional information (20-nov-2017): siemens investigated alternate statistical methods to evaluate the reference range data published in the instructions for use (ifu) and determined if an alternate method would provide a more robust fit for the data.Our investigation concluded that the lms (statistical smoothing method to re-evaluate the original ifu data) provided a better fit to the data and produced ranges consistent with the expected physiological change in insulin-like growth factor i (igf-i) levels compared to use of the weighted average results reported in the ifu.The current immulite systems igf-1 ifu expected values are computed using a weighted average of ordered data points near the specified percentile.Computing the expected values using the lms method, a centile smoothing method, generates ranges that are more appropriate for diagnostic use.Customer notification "insulin-like growth factor i (igf-1) revised reference ranges" imc18-03.A.Ous was sent to the ous customers and imc18-03.A.Us was sent to the us customers in november 2017.Mdrs 2432235-2017-00385_s4 and 2432235-2017-00420_s3 were filed for the same event.

Manufacturer Narrative

The initial mdr 2432235-2017-00424 was filed on 14-jul-2017.The first supplemental mdr 2432235-2017-00424_s1 was filed on 13-sep-2017.The second supplemental mdr 2432235-2017-00424_s2 was filed on 27-nov-2017.The third supplemental mdr 2432235-2017-00424_s3 was filed on dec-12-2017.Additional information (20-nov-2017): updated to align with the information provided in third supplemental mdr 2432235-2017-00424_s3 filed on dec-12-2017.

• 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: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 6715078
• MDR Text Key: 80219845
• Report Number: 2432235-2017-00424
• Device Sequence Number: 1
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: 00630414601236
• 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: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• 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: 116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• 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