MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION HEMOGLOBIN A1C KIT (A1C)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens and reported observation of elevated dimension hemoglobin a1c (hba1c) results which were discordant related to repeat testing.Siemens reviewed the instrument data and the information provided by the customer.The customer stated that the previous a1c calibration performed prior to testing patient samples was unacceptable, as the slope and correlation coefficient results were out of specification limits; however, the failed calibration was manually accepted by the customer.Siemens reviewed the quality control (qc) data and observed that the qc results were within acceptable ranges.The customer subsequently recalibrated the a1c assay and the calibration was successful.Based on the available information, the cause of the event was consistent with user error, as the customer did not perform the a1c calibration in accordance with the operator¿s guide/ifu instructions and manually accepted a failed calibration.The issue was resolved after performing recalibration of the a1c assay.The issue was resolved by routine troubleshooting; a product problem was not identified.Customer is operational and no further actions are required.
Event or Problem Description
The customer reported observation of elevated dimension hemoglobin a1c (hba1c) results which were discordant related to repeat testing when using lot: ga6344.The customer used an invalid calibration which resulted in above assay range results accompanied by an instrument error.The operator¿s guide/instructions for use (ifu) instructions were not followed, as the customer disregarded the error messages and did not perform the required manual dilution procedure per the ifu.Discordant hba1c patient sample results were reported for two (2) patient samples.For one (1) patient sample with sid: (b)(6), the discordant result was questioned by the physician which contributed to the cancellation of a scheduled surgery.The patient was retested at an alternate laboratory which yielded a lower (normal) result.The initial patient sample was subsequently retested on the original analyzer using the invalid calibration and continued to yield a higher result.For the other patient sample, the initial result was reported to the physician but was not questioned.The patient sample was subsequently retested on the original analyzer which yielded a lower result.The lower result was considered correct and was issued on corrected report to the physician.There were no allegations of patient harm due to the reported event.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION HEMOGLOBIN A1C KIT (A1C)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25187212
• Report Number: 2517506-2026-00084
• Device Sequence Number: 10693136
• Product Code: PDJ
• UDI-Device Identifier: 00630414006659
• UDI-Public: (01)00630414006659(10)GA6344(17)261210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 10720883
• Device Lot Number: GA6344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown