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

Catalog Number 05168791190

Device Problem Contamination (1120)

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

Event Date 09/13/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with gluc3 (glucose) on a cobas 8000 c702 module.No units of measure were provided.The first sample initially resulted in a glucose value of 1.02 and it repeated as 6.48.The second sample initially resulted in a glucose value of 2.36 and it repeated as 5.48.

Manufacturer Narrative

The photometer check result was normal.The field service engineer performed cleaning and maintenance on the analyzer.Precision studies were performed and the results were ok.The investigation determined the issue was resolved by the field service engineer's actions.

• Brand Name: GLUC3
• Type of Device: 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: 17746575
• MDR Text Key: 323807896
• Report Number: 1823260-2023-02979
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168791190
• Device Lot Number: 71146601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1