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

Catalog Number 08057800190

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 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the c 503 analyzer is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with glucose hk gen.3 on a cobas pro c 503 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in a glucose value of 12.7 mg/dl.The value did not agree with the patient's clinical status, so it was repeated.The sample was repeated on a second analyzer, resulting in a glucose value of 85.6 mg/dl.The repeat value was deemed correct as it matched the patient's clinical status.

Manufacturer Narrative

The field service engineer found no issues with the analyzers.Precision studies were performed and were acceptable.Controls and a hardware check passed.The investigation could not identify a product problem.The cause of the event could not be determined.The issue was resolved after the service actions.

• 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: 18239958
• MDR Text Key: 329396423
• Report Number: 1823260-2023-03808
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 12/22/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Male