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

Catalog Number	04657527190
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	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 111 analyzer is (b)(6).The customer stated that controls run the morning of the event were acceptable.A review of quality control data showed that controls mainly recovered outside of two standard deviations low.The customer has used a new reagent lot number for 6 days.Calibration, controls, and patient recovery have been acceptable.The investigation is ongoing.
Event or Problem Description
The customer stated that for two weeks, they have been having issues with questionable patient results for glucose hk on a cobas c 111 analyzer.The customer provided two examples of patient samples with discrepant glucose results.The first sample initially resulted in a glucose value of 0.3 mmol/l and it repeated as 0.4 mmol/l.A new reagent bottle of the same lot was then used to repeat the sample on (b)(6) 2024 and it recovered with a glucose value of 4.9 mmol/l.The second sample initially resulted in a glucose value of 0.6 mmol/l.A new reagent bottle of the same lot was then used to repeat the sample on (b)(6) 2024 and it recovered with a glucose value of 10.0 mmol/l.
Additional Manufacturer Narrative
The customer changed the sample probe, but the issue still occurred.The field service engineer ran checks on the analyzer.Precision studies were performed and did not show any anomalies.The investigation did not identify a product issue.There was no evidence of a general instrument or reagent related issue.The issue is consistent with insufficient pre-analytic sample handling.

• 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: 19087056
• Report Number: 1823260-2024-01101
• Device Sequence Number: 7651486
• Product Code: CFR
• UDI-Device Identifier: 04015630922338
• UDI-Public: 04015630922338
• Combination Product (Y/N): Y
• Initial Reporter Country: WZ
• 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): 05/13/2024

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: 04/30/2025
• Device Catalogue Number: 04657527190
• Device Lot Number: 75603501
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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