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

Catalog Number	05168791190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is 1939-06.The investigation reviewed the calibration data from 29-jun-2022 to 03-jul-2023.The calibrations were within specifications.The investigation reviewed the quality control (qc) recovery data.Qc level 1 and qc level 2 recoveries were marked as "ok" on the date of event.Based on the calibration and qc data, the investigation ruled out a general reagent problem.The alarm trace on 05-jul-2023 had "12:42:abnormal sample aspiration" and "13:36: abnormal sample aspiration" alarms.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable gluc3 glucose hk gen.3 results from one patient sample tested on the cobas 8000 c702 module.The initial result was reported to a satellite laboratory.The satellite laboratory staff questioned the result as the patient had normal capillary glycemia.The sample was the patient's baseline sample for glucose load assessment.On 05-jul-2023, the initial result was 124.8 mg/dl the first repeat result was 174.9 mg/dl.A result of 174 mg/dl was reported to the satellite laboratory.On 06-jul-2023, the second repeat result was 175.4 mg/dl.The third repeat result was 72.9 mg/dl.The fourth repeat result was 74.3 mg/dl.
Additional Manufacturer Narrative
Based on the image from the cobas infinity middleware (two sample tubes with the same identification), the event was consistent with a sample mismatch issue.The investigation did not identify a product problem.

• Brand Name: GLUC3
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17461410
• Report Number: 1823260-2023-02514
• Device Sequence Number: 2634699
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K061048
• 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): 09/11/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 05168791190
• Device Lot Number: 69476601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/27/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/11/2023
• 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 Age: 34 YR
• Patient Sex: Female