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

Catalog Number	08057800190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(4).
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for glucose hk gen.3 (gluc3) on a cobas c 303 analytical unit.The initial result was < 0.2 mmol/l.The repeat result was 5.2 mmol/l.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer (fse) confirmed the cause of the event was contamination of the customer's water system (external provider).The external provider decontaminated the water system.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19361452
• Report Number: 1823260-2024-01521
• Device Sequence Number: 6500736
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 06/07/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 08057800190
• Device Lot Number: 734489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/08/2024
• 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: Unknown