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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 IGF-1 Back to Search Results
Model Number IIMMULITE 2000 IGF-1
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 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
The customer contacted a siemens customer care center.The customer believes that the issue was with patient sample.The cause of the discordant, falsely low igf-1 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 (igf-1) result on one patient sample on an immulite instrument.The sample was tested on an alternate platform, resulting higher.The result obtained on the immulite platform was not reported to the physician(s).The result obtained on the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low igf-1 result.
 
Manufacturer Narrative
The initial mdr 2432235-2017-00385 was filed on july 14, 2017.Corrected information (07/18/2017): the initial mdr stated "the customer contacted a siemens customer care center.The customer believes that the issue was with patient sample.The cause of the discordant, falsely low igf-1 result on one patient sample is unknown.Siemens is investigating the issue." the customer believed it to be a sample issue for sample id (b)(6), not for sample id (b)(6).For sample id (b)(6), the cause of the discordant, falsely low igf-1 result on one patient sample is unknown.Siemens is investigating the issue.Corrected information (07/18/2017): the initial report of 2432235-2017-00385 mentioned that the sample id affected was (b)(6).Additional information has been received stating that the data provided was incorrect and was for sample id (b)(6).The igf-1 result of 46.7 ng/ml belonged to sample id (b)(6), however, result of 1002.10 ng/ml belonged to sample id (b)(6).Sample id (b)(6) was not repeated on an alternate platform.Additionally, the discordant result was obtained on immulite 2000 xpi instrument and the date of event occurrence was (b)(6) 2017.Additional information (07/18/2017).The customer provided the lot # for the igf-1 assay.The affected kit lot # is 561.Mdrs 2432235-2017-00385, 2432235-2017-00420 and 2432235-2017-00424 were filed for the same event.
 
Event Description
The customer obtained imprecise insulin-like growth factor i (igf-1) results on one patient sample on an immulite 2000 xpi instrument when run with old igf-1 method vs.Re-standardized igf-1 method.The kit lot # being used for igf-1 re-standardized method was 116 and for old igf-1 method was 561.The repeat result obtained with igf-1 method was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the imprecise igf-1 results.
 
Manufacturer Narrative
The initial mdr 2432235-2017-00385 was filed on july 14, 2017.The first supplemental mdr 2432235-2017-00385_s1 was filed on july 20, 2017.The second supplemental mdr 2432235-2017-00385_s2 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 2432235-2017-00385 was filed on july 14, 2017.The first supplemental mdr 2432235-2017-00385_s1 was filed on july 20, 2017.Additional information (08/25/2017): a siemens headquarters support center specialist reviewed the event data and determined that for sample id (b)(6), results obtained using insulin-like growth factor i (igf-1) vs.Igf-1 (re-standardized) assay fall within the same diagnostic range.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.
 
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 2432235-2017-00420_s3 and 2432235-2017-00424_s3 were filed for the same event.
 
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Brand Name
IMMULITE 2000 IGF-1
Type of Device
IMMULITE 2000 IGF-1
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 Key6715073
MDR Text Key80266717
Report Number2432235-2017-00385
Device Sequence Number1
Product Code CFL
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received07/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIIMMULITE 2000 IGF-1
Device Lot Number561
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2017
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
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age8 YR
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