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

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	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an erroneously elevated hemoglobin a1c assay (a1c) result was obtained on a patient sample on a dimension exl with lm integrated chemistry system.The erroneous result was not reported to the physician(s).The sample was sent to an alternate lab and reprocessed on a non-siemens system.The reprocessed result was lower than the erroneous result.The reprocessed result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated hemoglobin a1c assay (a1c) result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens remote services center (rsc) and reported that an erroneously elevated hemoglobin a1c assay (a1c) result was obtained on a patient sample on a dimension exl with lm integrated chemistry system.Quality control (qc) was within range on the day of the event.Siemens concluded the investigation of the event.Siemens reviewed the available instrument data files, and the information provided by the customer.Siemens¿ review identified that the calibration results prior to the day of the event with the other reagent lot# gb7014 from the 4th and 5th runs were low.However, the customer manually accepted this failed calibration.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse performed all probe alignments, verified the photometer and cuvettes, reviewed the calibration, and observed issues with replicates.The cse confirmed that the customer had not added enough calibrator to the cups, which caused the accepted calibration to skew patient value.The instructions for use (ifu) states that "calibration cups must be filled with 600 l of calibrator".The customer reran the calibration for the a1c assay in accordance with the ifu guidelines using enough calibrator, which passed, and the reported event was resolved.Siemens evaluated the event and determined that user error, specifically by running not enough calibrator in the cups and inadvertently accepting the failed calibration, potentially contributed to the erroneously elevated a1c result.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2026-00073 on 26-apr-2026.Additional information (28-apr-2026): the customer confirmed that they reported patient samples only using lot number ga6295.Based on this additional information, siemens reassessed the cause of the event.Correction: please disregard the investigation findings code (c1302 - failure to calibrate or used out of calibration) and the investigation conclusions code (d11 - cause traced to user) in section h6 of the initial mdr.Also, please disregard the following statements in section h11 of the initial mdr.¿the cse confirmed that the customer had not added enough calibrator to the cups, which caused the accepted calibration to skew patient value.The customer reran the calibration for the a1c assay in accordance with the ifu guidelines using enough calibrator, which passed, and the reported event was resolved.Siemens evaluated the event and determined that user error, specifically by running not enough calibrator in the cups and inadvertently accepting the failed calibration, potentially contributed to the erroneously elevated a1c result.¿ the disregarded statements should be replaced with the following correct statements: "the cse confirmed that the customer had not added enough calibrator to the cups when ran with the other lot number gb7014.The customer reran the calibration for the a1c assay in accordance with the instructions for use (ifu) guidelines using enough calibrator, which passed.However, the calibration with the affected lot# ga6295 was acceptable on the day of the event.Based on the available information, the cause of the erroneously elevated hemoglobin a1c assay (a1c) result is unknown." the investigation conclusions code of section h6 was updated to reflect the correct (additional) information.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION HEMOGLOBIN A1C KIT
• 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: 24993489
• Report Number: 2517506-2026-00073
• Device Sequence Number: 9655247
• Product Code: PDJ
• UDI-Device Identifier: 00630414006659
• UDI-Public: (01)00630414006659(10)GA6295(17)261022
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 04/29/2026

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: GA6295
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/26/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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