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

Catalog Number	04657527190
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	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The field service engineer (fse) verified that the analyzer probe was clean and correctly adjusted.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable gluc3 glucose hk gen 3 results for 1 patient sample on a cobas c 111 analyzer.The customer aliquoted serum into an eppendorf tube on the top of the primary sample tube and the initial glucose result was 666.8 mg/dl.Another serum sample collected at the same time with aliquoted serum in an eppendorf tube on top of the primary tube was tested and the result was 167.3 mg/dl.A heparin plasma sample collected at the same time as the initial serum sample was tested and the glucose result was 165.9 mg/dl.The initial primary serum sample was repeated again without an eppendorf tube and the result was 168.8 mg/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The root cause of the event was found to be consistent with using an eppendorf cup (not recommended by roche) placed upon the primary tube.The investigation did not identify a product problem.

• 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: 20033458
• Report Number: 1823260-2024-02439
• Device Sequence Number: 6508368
• Product Code: CFR
• UDI-Device Identifier: 04015630922338
• UDI-Public: 04015630922338
• Combination Product (Y/N): Y
• Initial Reporter Country: VM
• 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): 09/20/2024

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: 10/31/2025
• Device Catalogue Number: 04657527190
• Device Lot Number: 79843401
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• 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