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

Catalog Number	04404483190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration results were acceptable.Quality control results in the time period from (b)(6) 2023 to (b)(6) 2023 were not stable and show outliers.No quality control data was provided from the date of the event.Upon review of the alarm trace, no relevant alarm was observed.The field service engineer replaced the sample probe.The issue did not re-occur.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a pre-analytical sample handling issue, leading to a contaminated sample probe.Na.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the gluc3 (glucose hk gen.3) assay on a cobas 8000 cobas c 502 module, serial number (b)(4).Patient sample 1, tested on (b)(6) 2023: the sample initially resulted in a gluc3 value of 0.01 mmol/l and repeated as 5.54 mmol/l patient sample 2, tested on (b)(6) 2023: the sample initially resulted in a gluc3 value of 0.01 mmol/l and repeated as 7.26 mmol/l.No questionable results were reported outside of the laboratory.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16478340
• Report Number: 1823260-2023-00639
• Device Sequence Number: 3198690
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 03/03/2023

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: 04404483190
• Device Lot Number: 69826801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/03/2023
• 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 Sex: Unknown