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

Catalog Number 08057800190

Device Problem Low Test Results (2458)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable gluc3 glucose hk gen.3 results for 1 patient sample on a cobas pro c 503 analytical unit.The initial glucose result was 21.7 mg/dl.The customer questioned the low result and repeated the sample.The repeat result was 83.7 mg/dl.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service engineer (fse) changed the sample probe, replaced the heat cut filter, adjusted the rinse levels, cleaned the reagent probes and a solenoid valve, and performed a cell blank successfully.The customer performed qc successfully.The investigation is ongoing.

Manufacturer Narrative

The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: GLUCOSE HK GEN.3
• Type of Device: GLUCOSE HEXOKINASE
• 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: 17860675
• MDR Text Key: 324797020
• Report Number: 1823260-2023-03164
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191899NA
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057800190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• 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