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

Catalog Number	04404483190
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	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 501 module is (b)(6).Calibration data was acceptable.Controls recovered within range.Upon review of the alarm trace, no relevant alarms were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with cobas integra glucose hk gen.3 on a cobas 6000 c501 module.The sample initially resulted in a glucose value of 0.7 mg/dl and it repeated as 123.3 mg/dl.The 123.3 mg/dl value was expected for the patient.
Additional Manufacturer Narrative
Upon review of the reaction monitor, the reaction appeared abnormal, as if not enough sample was pipetted.Calibration data was ok.Quality controls were ok.A general reagent issue can be ruled out since calibration and controls are acceptable.No relevant alarms were observed in the alarm trace.The field service engineer replaced the gear pump head and adjusted the pressure.The sample probe and syringe seals were replaced.The wash and sample probe adjustments were checked and were ok.The rinse station was checked and it was ok.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS INTEGRA GLUCOSE HK GEN. 3
• 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: 18144318
• Report Number: 1823260-2023-03618
• Device Sequence Number: 15355876
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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): 12/13/2023

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: 11/30/2024
• Device Catalogue Number: 04404483190
• Device Lot Number: 74348401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/13/2023
• 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