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

Catalog Number	04404483190
Medical Device Problem Codes	Low Test Results (2458); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c501 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results occurring with multiple assays from the cobas 6000 c501 module.Glucose hk gen.3 results were provided for 1 patient that is a reportable malfunction.The initial result was 1.35 mmol/l, and the repeat result was 8.24 mmol/l.The initial result was repeated because the doctor and patient questioned it, as it did not match the clinical picture.
Additional Manufacturer Narrative
A field service engineer (fse) replaced the turntable and adjusted the rinse volume.The investigation determined that the direct root cause was a component malfunction.The issue was locally solved in a commonly trained troubleshooting process.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21893950
• Report Number: 1823260-2025-01255
• Device Sequence Number: 8272921
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 06/25/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 04404483190
• Device Lot Number: 821197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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