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

Catalog Number	08057800190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two samples from the same patient tested with the gluc3 (glucose hk gen.3) assay on a cobas pro sample supply unit, serial number (b)(6).The first sample initially resulted in a gluc3 value of 3651 mg/dl.A second sample was taken close in time, resulting in a gluc3 value of 93 mg/dl.The initial reporter alleged concerns with pseudohyponatraemia caused by hyperglycaemia.This medwatch will apply to the gluc3 assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6).For information related to the sodium results.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The customer did not provide any additional information for the investigation.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: GLUCOSE HK GEN.3
• Common Device Name: GLUCOSE HEXOKINASE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16809595
• Report Number: 1823260-2023-01399
• Device Sequence Number: 6072258
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191899
• 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): 05/16/2023

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: 08057800190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/16/2023
• 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
• Patient Sex: Unknown