MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 THYROGLOBULIN

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A us customer contacted the siemens customer care center (ccc) to report imprecision on level 1 quality control samples and occasional quality results recovering outside of specifications on the immulite 2000 systems when using thyroglobulin kit lot d431.The issue was observed on all 4 immulite systems in the customer's laboratory.Siemens healthcare diagnostics further investigated the issue and has confirmed the potential for functional sensitivity to not meet instructions for use claims with thyroglobulin kit lots d431-d436 (us) and kit lots 431-436 (outside the us).Investigation has also demonstrated that immulite thyroglobulin control module control level one may result outside of published ranges.Per good laboratory practice, patient results are not reported when controls result out of range.When control results are in range, users may observe increased imprecision with low level patient samples.An urgent medical device correction (b)(4) was sent to us customers on (b)(6) 2022, and an urgent field safety notice (b)(4) was sent to outside the us (ous) customers on (b)(6) 2022.The umdc and ufsn explain the potential for functional sensitivity not meeting ifu claims and increased imprecision with patient samples with low level patient samples.
Event or Problem Description
The customer indicated imprecision on level 1 quality control samples and occasional quality results recovering outside of specifications on the immulite 2000 systems when using thyroglobulin kit lot: d431.The issue was observed on all 4 immulite systems in the customer's laboratory.The customer performed a patient sample correlation between d431 and d429, and the results were acceptable.Results were not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the failed quality control samples.

• Brand Name: IMMULITE 2000 THYROGLOBULIN
• Common Device Name: IMMULITE 2000 THYROGLOBULIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer Contact: karen confort ; 511 benedict avenue; tarrytown, NY 10591 ; 3392069063
• MDR Report Key: 15950409
• Report Number: 2432235-2022-00314
• Device Sequence Number: 15057614
• Product Code: MSW
• UDI-Device Identifier: 00630414972084
• UDI-Public: 00630414972084
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K982458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381647
• Device Lot Number: D431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-12/06/2022-006-C
• Patient Sequence Number: 1
• Patient Sex: Unknown