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

Catalog Number 04404483190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas 6000 c 501 serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of a questionable gluc hk gen.3 (glucose) result from the cobas 6000 c 501.The initial result was 2 mg/dl and was reported outside of the laboratory.The repeat result was 77 mg/dl and was believed correct.

Manufacturer Narrative

The customer canceled a scheduled service visit and stated they resolved the issue by recalibrating the assay.The investigation determined the customer's actions resolved the issue.

• 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: 18039245
• MDR Text Key: 326969979
• Report Number: 1823260-2023-03475
• 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,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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: 11/16/2023
• 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