MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYVA® EMIT ® 2000 TACROLIMUS; ENZYME IMMUNOASSAY, TACROLIMUS

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 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

An outside united states (ous) customer contacted a siemens remote support center (rsc) to report quality control (qc) failures and erroneous patient results with syva® emit® 2000 tacrolimus results that were obtained on viva-e® analyzer.The following maintenance and troubleshooting steps were performed: checked cuvettes, dry block, mixer bearing, belt , valve kits, maintenance diluter¿ replaced cuvette sand dry block, replace wash solution, replace 0.1n hcl,10%naclo n hcl,10%naclo, decontamination of system with micro clean, do checkr&check scv%<1micro clean.Checkr&check scv%<1.Replaced the reagent and repeated tests.The limitations section of the syva® emit® 2000 tacrolimus assay instructions for use (ifu) states: "results of this test should always be interpreted in conjunction with the patient¿s medical history, clinical presentation and other findings." siemens is investigating.

Event Description

The customer reported syva® emit ® 2000 tacrolimus results for multiple patient samples on the viva-e® analyzer, that were considered erroneous to repeat testing on the same analyzer.Only results considered correct by the laboratory were reported to the physician(s).Additionally quality control (qc) recovered within range after reprocessing several times.Patient samples were not processed when qc was out of range.Patient results were reported only when qc was in range.There are no known reports of patient intervention or adverse health consequences due to event.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2024-00046 on 02-feb-2024.Additional information 21-mar-2024: siemens performed initial testing and referred the data for further review.Additional information 12-apr-2024: siemens investigated this issue and provided the following conclusion: the expected behavior of the syva® emit® 2000 tacrolimus assay reagent is as follows: information summarized below can be attained in the product instructions for use (ifu), instrument application sheet, and vendor¿s control documentation.The reagent ifu states that the reagents will remain stable after opening for 12 weeks or until the expiration date printed on the label (whichever is sooner), pending that they are stored at 2 ¿ 8°c, upright, and with caps tightly closed.Ifu states to refer to application sheet for complete instructions.Application sheet states that reagents may be stored onboard, capped when not in use for up to 4 weeks or as quality control (qc) results are within acceptable limits.Qc expected ranges are provided by the vendor, with the expectation that individual laboratories will develop their own qc ranges using the expected ranges as a guideline.The syva ifu also provides instruction for the testing laboratory to generate their own qc ranges and states that in the event of a qc failure the testing laboratory is required to follow the laboratory¿s quality procedures.The customer is alleging instability in reagent observed by qc results drifting/failing low and inconsistent clinical sample results.When qc results drift/fail low the customer is required to re-calibrate and to perform additional troubleshooting.Since the atellica ch lot 130034 contains the same reagent used in the syva emit 2000 tacrolimus reagent lot s1 and the viva-e and the atellica ch use the same principle of spectroscopy to measure analyte concentration in calibrator, control, or patient sample, siemens performed testing using the atellica ch reagent lot 130034.The principle of spectroscopy used is based on measuring the absorbance of light at 340 during the reaction between sample, reagent 1, and reagent 2.Siemens' review of the atellica ch data did not confirm the observations reported by the customer.The syva emit 2000 tacrolimus assay reagent has no calibration interval claims and the viva-e application sheet instructs the operator to ¿prepare a calibration curve whenever a new lot of reagents are used or as indicated by control results¿.The product problem identified by the customers is not confirmed.Customer sample handling methods cannot be ruled out as a potential result in adverse assay performance.The syva emit 2000 tacrolimus assay lot s1 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.The investigation findings and investigation conclusions codes were updated.

• Brand Name: SYVA® EMIT ® 2000 TACROLIMUS
• Type of Device: ENZYME IMMUNOASSAY, TACROLIMUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 18630341
• MDR Text Key: 334493676
• Report Number: 2517506-2024-00046
• Device Sequence Number: 1
• Product Code: MLM
• UDI-Device Identifier: 00842768001666
• UDI-Public: 00842768001666
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060385
• 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
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10445397
• Device Lot Number: S1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1