MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH REACTION CUVETTE SEGMENT; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	N/A
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported quality control (qc) imprecision for the salicylate (sal) assay on the atellica ch 930 analyzer.The customer stated that no patient samples were reported while the quality control (qc) was out of range.No patient results were impacted or reported.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed imprecision.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report quality control (qc) imprecision for the salicylate (sal) assay on the atellica ch 930 analyzer.Siemens healthineers has confirmed there is a potential for imprecision with the atellica ch salicylate (sal) assay due to optical sensitivity when using a subset of lots of atellica ch reaction ring cuvette segments on some atellica ch analyzers.Us customers were notified of this behavior through an urgent medical device correction (umdc, letters achc25-01.A.Us and achc25-01.B.Us) and ous customers were informed through an urgent field safety notice (ufsn, letters achc25-01.A.Ous and achc25-01.B.Ous) titled ¿atellica ch reaction ring cuvette segments may cause imprecision on seven (7) assays¿.The communication was directed to all customers who received the impacted lots of atellica ch reaction ring cuvette segments informing them of the issue and providing instructions customers must follow.Note: for section d4, the customer did not provide the lot number that was used at the time of the event.The udi number is unknown.Therefore, the gtin was provided.

• Brand Name: ATELLICA CH REACTION CUVETTE SEGMENT
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): NYPRO, INC.; 101 union street; registration # 3010665957; clinton MA 01510
• Manufacturer Contact: eiman sulieman ; 511 benedict ave.; tarrytown, NY 10591 ; 7372808688
• MDR Report Key: 20586379
• Report Number: 2432235-2024-00278
• Device Sequence Number: 8787577
• Product Code: JJE
• UDI-Device Identifier: 00630414596143
• UDI-Public: 00630414596143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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 Model Number: N/A
• Device Catalogue Number: 11099326
• Device Lot Number: REFH10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 2432235-10/23/2024-004-C
• Patient Sequence Number: 1
• Patient Sex: Unknown