MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUCOSE HK GEN.3; GLUCOSE HEXOKINASE

Catalog Number	08057800190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2nd and 3rd repeat results were obtained using gluc3 reagent lot number 822380.The expiration dates of both gluc3 reagent lot numbers 809710 and 822380 were not provided.The cobas pure c303 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with glucose hk gen.3 (gluc3) assay on a cobas pure c303 analytical unit.Initial result: 0.0122 mmol/l (accompanied by a data flag).1st repeat result: -0.00323 mmol/l (accompanied by a data flag).The sample was then repeated on a different cobas pure instrument at the same facility using a different lot number.The 2nd and 3rd repeat results were both 0.00673 mmol/l (accompanied by data flags).The customer suspected an interference with the applied treatment.
Additional Manufacturer Narrative
The investigation excluded a reagent/instrument issue, as the result was repeatable on two different analyzers.The investigation excluded the interference of an exogenous substance based on the application report.The patient was terminally ill with acute myeloid leukemia (aml) after the start of the thirteenth chemotherapy cycle and was transferred to the intensive care unit (iu).The investigation determined the event was consistent with the patient's complex and critical medical state.The investigation did not identify a product problem.

• Brand Name: GLUCOSE HK GEN.3
• Common Device Name: GLUCOSE HEXOKINASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21993038
• Report Number: 1823260-2025-01429
• Device Sequence Number: 19899400
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K191899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 08/11/2025

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 Catalogue Number: 08057800190
• Device Lot Number: 809710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AZACITIDIN (CHEMOTHERAPY)
• Patient Sex: Unknown