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

Catalog Number 04404483190

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 310618105
• Report Number: 1823260-2023-00639
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1