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

Catalog Number 05168791190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The c 702 module serial number was (b)(6).The competitor urine strip was the sysmex uc-3500.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 326796480
• Report Number: 1823260-2023-03458
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• Combination Product (y/n): Y
• Reporter Country Code: SI
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 05168791190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JARDIANCE; R-CHOP; ZARZIO