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

Catalog Number	04404483190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable glucose hk gen.3 results for 1 patient serum sample on a cobas 4000 c311 stand alone system and 7 patient urine samples compared to a competitor analyzer.Sample 1 had an initial serum glucose result of 129.7 mg/dl.The repeat result was 85.6 mg/dl.Sample 2 had a urine glucose result of 6.97 mg/dl.The urine glucose result from a h-800 urine analyzer was 100 mg/dl.Sample 3 had a urine glucose result of 5.66 mg/dl.The urine glucose result from a h-800 urine analyzer was 100 mg/dl.Sample 4 had a urine glucose result of 2.42 mg/dl.The urine glucose result from a h-800 urine analyzer was 100 mg/dl.Sample 5 had a urine glucose result of 1.51 mg/dl.The urine glucose result from a h-800 urine analyzer was 100 mg/dl.Sample 6 had a urine glucose result of 7.98 mg/dl.The urine glucose result from a h-800 urine analyzer was 100 mg/dl.Sample 7 had a urine glucose result of 716 mg/dl.The urine glucose result from a h-800 urine analyzer was >100 mg/dl.Sample 8 had a urine glucose result of 2.24 mg/dl.The urine glucose result from a h-800 urine analyzer was 100 mg/dl.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer stated that their reference ranges were outdated.Following the implementation of updated reference values, the observed results were consistent with the system's performance.The investigation determined that the customer's incorrect reference ranges had caused the event.No product problem was identified.

• 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: 24324885
• Report Number: 1823260-2026-00504
• Device Sequence Number: 21217834
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 08/31/2026
• Device Catalogue Number: 04404483190
• Device Lot Number: 88232801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/17/2026
• 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
• Patient Sex: Unknown