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

Catalog Number 05168791190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable gluc3 glucose hk gen.3 results for 1 patient urine sample on a cobas 8000 cobas c 701 module.The initial gluc3 results with and without auto-dilution were accompanied by a flag indicating the values were above the linearity/measuring range of the assay.This prompted the customer to perform a manual 1:5 dilution of the patient sample.The manual 1:5 dilution result was 18.45 g/l.The sample was sent to another laboratory and tested on another c701 analyzer.The sample was re-centrifuged and the result without dilution was 3.3 g/l.No questionable results were reported outside of the laboratory.The customer's analyzer serial number is (b)(4).

Manufacturer Narrative

The qc recovery data provided was acceptable.The investigation is ongoing.

Manufacturer Narrative

The calibration trace data provided was acceptable.The field service engineer found the analyzer was within specification.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 16594914
• MDR Text Key: 312220852
• Report Number: 1823260-2023-00930
• 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,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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: 674271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• 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