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

Catalog Number 08057800190

Device Problem Non Reproducible Results (4029)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable glucose hk gen.3 results for one patient tested on a cobas c 503 analytical unit serial number (b)(4).The patient had two urine samples tested for glucose.The patient's questionable glucose results were reported outside the laboratory.The customer performed repeat testing with both samples.The "biologist discussed about these curious increasing glucose results from urine of this patient with his physician." the patient's first sample had an initial glucose result of "around 1000" mg/dl."around one hour later," the patient's first repeat glucose result was "around 2000" mg/dl.The first sample was tested "later" and the patient's second repeat glucose result was "around 2500" mg/dl.The patient's second sample had an initial glucose result of "around 800" mg/dl.The patient's repeat glucose result "later" was "around 1200 mg/dl.".

Manufacturer Narrative

The customer's calibration and qc results, sample reaction monitors, and system alarm trace were requested but not provided.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12575930
• MDR Text Key: 274763721
• Report Number: 1823260-2021-02906
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K191899
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 08057800190
• Device Lot Number: 51902501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• 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
• Treatment: UNSPECIFIED DIABETES MEDICATION; UNSPECIFIED DIABETES MEDICATION