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

Catalog Number	04657527190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 111 analyzer serial number was (b)(6).A general reagent problem was ruled out because calibration and quality control were acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable glucose hk result from the cobas c 111 analyzer.The initial result was 184 mg/dl.The repeat result was 93 mg/dl.This result was believed to be correct.The user repeated the sample 5 times and the results were all 106-107 mg/dl.
Additional Manufacturer Narrative
The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21322452
• Report Number: 1823260-2025-00350
• Device Sequence Number: 18263978
• Product Code: CFR
• UDI-Device Identifier: 04015630922338
• UDI-Public: 04015630922338
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/12/2025

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: 04657527190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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 Age: 6 YR
• Patient Sex: Female