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

Catalog Number 05168791190

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

Upon review of the alarm trace, several abnormal aspiration alarms were observed.The customer declined, to provide any additional information and to perform an instrument check.The customer thinks the root cause is preanalytics (bubble).The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated, they received discrepant results for one patient sample tested with the gluc3 (glucose hk gen.3), assay on a cobas 8000 cobas c 701 module, serial number (b)(4).The sample initially resulted in a gluc3 value of 0.00 mmol/l, and repeated as 5.23 mmol/l.No questionable result was reported outside of the laboratory.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16941728
• MDR Text Key: 315337737
• Report Number: 1823260-2023-01653
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630925025
• UDI-Public: 04015630925025
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 05168791190
• Device Lot Number: 67427101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• 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