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

Catalog Number	04404483190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus serial number is (b)(6).The field service engineer classified the cause of the event as undetermined.To address the issue, he inspected the analyzer, verified the mechanisms and the parts, including the sample probes; he found all components to be in good working order.He verified the analyzer's performance with successful precision checks.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable glucose hk gen.3 results from one patient sample tested on the cobas integra 400 plus.The initial result from the analyzer was 408.4 mg/dl with a data flag.The first repeat result from the analyzer was 409.2 mg/dl the second repeat result from the analyzer was 408.4 mg/dl.The result from a freestyle lite glucometer was 240 mg/dl.The time interval between the tests was not provided.The reporter and the doctor questioned the result because it did not match the previous patient's history in the chart.The doctor used the result from the glucometer.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the glucose hk gen.3 calibration and qc results are within the specified ranges.The alarm trace contains clot-detected alarms.These are indicators of possible poor sample quality.The customer confirmed that they allow the patient samples to clot for 20 to 30 minutes before centrifugation.The investigation determined that clotting may be incomplete in 20 minutes.The customer confirmed that the cobas integra 400 plus analyzer's results were correct, and that, upon consultation with the patient's doctor, the elevated results were due to a side effect of the patient's medication.The investigation did not identify a product problem.

• Brand Name: GLUCOSE HK GEN.3
• Common Device Name: HEXOKINASE, GLUCOSE
• 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: 24200759
• Report Number: 1823260-2026-00305
• Device Sequence Number: 18594305
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/19/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 04404483190
• Device Lot Number: 84976801
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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: PREDNISONE
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG