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

Catalog Number 04404483190

Device Problem Low Test Results (2458)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).Calibration was last performed on 23-aug-2023.The qc recovery data provided was acceptable.The customer stated they replaced the glucose reagent and performed qc and a precision check successfully.The service maintenance actions performed by the customer resolved the issue.No further issues were reported.

Event Description

There was an allegation of questionable gluc3 glucose hk gen.3 results for 3 patient samples on a cobas 6000 c (501) module.The customer was prompted the repeat the samples as the initial results seemed too low.For sample 1, the initial glucose result was 3 mg/dl.The sample was repeated on another c501 analyzer and the result was 215 mg/dl.For sample 2, the initial glucose result was 3 mg/dl.The sample was repeated on another c501 analyzer and the result was 298 mg/dl.For sample 3, the initial glucose result was 2 mg/dl.The sample was repeated on another c501 analyzer and the result was 115 mg/dl.The repeat results were deemed correct.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18177514
• MDR Text Key: 328643841
• Report Number: 1823260-2023-03705
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04404483190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• 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