MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC3; HEXOKINASE, GLUCOSE

Catalog Number	05168791190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c 702 module serial number was (b)(6).The competitor urine strip was the sysmex uc-3500.
Event or Problem Description
The initial reporter questioned a high gluc3 assay result for 1 patient's urine sample tested on a cobas 8000 c 702 module.The urine results were >abs "several" times.When diluted x10, the urine result was 243.4 mmol/l.The result from a competitor urine strip was 111 mmol/l.The glucose result from the serum sample was 6.1 mmol/l.The customer is wondering about possible interferences that could affect the urine glucose result as it is not consistent with the serum glucose result.
Additional Manufacturer Narrative
The root cause of the event was found to be consistent with the actions of the drug jardiance.According to the drug's manufacturer, the drug blocks a specific protein in the kidneys which increases glucose secretion in urine.Based on the available data, a general reagent issue could be excluded.

• Brand Name: GLUC3
• 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: 18028330
• Report Number: 1823260-2023-03458
• Device Sequence Number: 20573374
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• Combination Product (Y/N): Y
• Initial Reporter Country: SI
• 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): 11/13/2023

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: 05168791190
• Device Lot Number: ASKU
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: JARDIANCE; R-CHOP; ZARZIO
• Patient Sex: Unknown