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

Catalog Number	04404483190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable glucose hk gen.3 results for 2 patient plasma samples on a cobas 6000 c (501) module.The customer was prompted to repeat the initial results as they have protocols to repeat all ciritical values.For sample 1, the initial glucose result was 19 mg/dl.The sample was repeated on another module and the result was 89 mg/dl.For sample 2, the initial glucose result was 39 mg/dl.The sample was repeated on another module and the result was 119 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer performed a precision and correlation study successfully.The field service engineer (fse) observed worn out rinse tubing and replaced it.The fse adjusted rinse volume and performed mechanical checks, a precision test, and cell blanks successfully.The customer performed qc successfully.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on 09-jul-2025.On the day of the event, the customer has multiple failed calibration attempts and received several calibration errors.The alarm trace showed abnormal probe sucking, abnormal sample aspiration, and sample short errors.It was found that the customer was centrifuging samples for 5 minutes at 4000 rpm, which may be too short of a time and at a spin speed that is faster than recommended.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 22955111
• Report Number: 1823260-2025-02716
• Device Sequence Number: 21211132
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 04404483190
• Device Lot Number: 836475
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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
• Patient Sex: Unknown