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

Catalog Number	04657527190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c111 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for glucose hk on a cobas c 111 analyzer.The initial result was "over" 200 mg/dl.The specific result could not be provided.The repeat result was 236.19 mg/dl.On (b)(6) 2026, the customer received a complaint that the patient¿s glucose result from a different laboratory was "normal." the specific result was not provided.The customer repeated the original sample, and the result was 79.68 mg/dl.
Additional Manufacturer Narrative
The result of 79.68 mg/dl from (b)(6) 2026 is not valid.The sample was stored for 2 weeks, including 1 week at room temperature.Serum glucose is stable for 3 days at 2¿8°c.Calibration and qc were acceptable.No maintenance issues were identified.The investigation determined the event was consistent with a preanalytical handling issue (patient sample mismatch).This is supported by the lack of clinical correlation with the patient's other test results.The investigation did not identify a product problem.

• Brand Name: GLUCOSE HK
• 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: 24615367
• Report Number: 1823260-2026-00934
• Device Sequence Number: 13158283
• Product Code: CFR
• UDI-Device Identifier: 04015630922338
• UDI-Public: 04015630922338
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K071211
• 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): 04/17/2026

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 Catalogue Number: 04657527190
• Device Lot Number: 886902
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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: Female