MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM; 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	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The 01-sep-2024 to 11-dec-2024 calibration data were within specifications.The 02-dec-2024 to 11-dec-2024 serum qcs were within specifications.The 02-dec-2024 to 08-dec-2024 urine qcs had borderline and outside -2 standard deviation range.A general reagent problem was ruled out because calibration and serum qcs were acceptable.The 01-dec-2024 to 11-dec-2024 had sample pipetting (sample short and sample aspiration) alarms.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable cobas integra glucose hk gen.3 test system result from one patient sample tested on the cobas 8000 c702 module.The initial result was 570 mg/dl.The first repeat result was 123 mg/dl.The second repeat result was 124 mg/dl.The initial result was not reported outside the laboratory as it did not match the patient's history.The repeat results were deemed to be the correct results.
Additional Manufacturer Narrative
Based on the information provided, the investigation did not identify a product problem.

• Brand Name: COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
• 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: 21067120
• Report Number: 1823260-2025-00016
• Device Sequence Number: 3409920
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 01/22/2025

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: 09/30/2025
• Device Catalogue Number: 05168791190
• Device Lot Number: 81205101
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/22/2025
• 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: Female