MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH GLUCOSE HEXOKINASE_3 (GLUH_3); HEXOKINASE, GLUCOSE

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	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted the siemens healthcare diagnostics regional support center (rsc) regarding erroneously elevated glucose hexokinase_3 (gluh_3) results obtained on patient samples on an atellica ch 930 analyzer.Quality control (qc) was performed and was within the acceptable range for one reagent pack.Qc was not performed for the other reagent pack, which was only calibrated.Siemens is investigating the event.
Event or Problem Description
The customer observed erroneously elevated glucose hexokinase_3 (gluh_3) results on patient samples that were obtained on the atellica ch 930 analyzer.The initial results were reported and questioned by the physician.The samples were reprocessed on an alternate atellica ch 930 analyzer.Data is unavailable.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated glucose hexokinase_3 results.
Additional Manufacturer Narrative
Additional information (12-jul-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument logs.Quality control (qc) did not recover within the customer¿s acceptable ranges.The calibration coefficient was found to be significantly lower when compared to other calibrations using the same reagent and calibrator lots.The customer resolved the issue by performing a new calibration for the same reagent lot.The customer stated the issue was resolved and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00149 was filed on 08-jul-2024.

• Brand Name: ATELLICA CH GLUCOSE HEXOKINASE_3 (GLUH_3)
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; registration # 8020890; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19696517
• Report Number: 2432235-2024-00149
• Device Sequence Number: 8122595
• Product Code: CFR
• UDI-Device Identifier: 00630414596488
• UDI-Public: 00630414596488
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K101854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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 Expiration Date: 12/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097592
• Device Lot Number: 232047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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