MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE® 2000 THYROGLOBULIN; THYROGLOBULIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Event Description

The customer observed a low bias with the immulite® 2000 thyroglobulin (tg) assay on a quality control and patient samples that ran on the immulite 2000 xpi instrument.The customer informed siemens that the initial results were correct and reported.The customer performed repeat testing on the same instrument for troubleshooting purposes.The customer did not report any tg patient results when quality control (qc) indicated a low bias or was out of range.There are no reports of patient intervention or adverse health consequences due to the low bias observed with the tg assay.

Manufacturer Narrative

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 (umdc, letter imc23-04.A.Us) was sent to us customers 12/8/2022, and an urgent field safety notice (ufsn, letter imc23-04.A.Ous) was sent to outside the us (ous) customers on 12/7/2022.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.Mdrs 2432235-2022-00372, 2432235-2022-00373, 2432235-2022-00374, 2432235-2022-00375, 2432235-2022-00376, and 2432235-2022-00380 were filed for the same event.

• Brand Name: IMMULITE® 2000 THYROGLOBULIN
• Type of Device: THYROGLOBULIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY
• 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; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 15943606
• MDR Text Key: 308351105
• Report Number: 2432235-2022-00377
• Device Sequence Number: 1
• Product Code: JNL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K982468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381648
• Device Lot Number: 431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2432235-12/06/2022-006-C
• Patient Sequence Number: 1