MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUC3 GLUCOSE HK GEN.3; HEXOKINASE, GLUCOSE

Catalog Number 04404483190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient tested for gluc3 glucose hk (gluc3) on a cobas 6000 c (501) module.The erroneous results were reported outside of the laboratory.The patient was suffering from ketoacidosis after ingesting "copious" amounts of (b)(6).The patient was initially tested on the radiometer blood gas analyzer and the result was 46 mmol/l.A sample was also obtained and tested on the c501 module were the first result was 65.6 mmol/l with a data flag.The auto repeat result on the c501 module was 91.7 mmol/l with a data flag.The operator then performed a 1:3 dilution and the result was 89 mmol/l.This result was reported outside of the laboratory.A second sample was obtained for the blood gas analyzer on the same day and the result was 47 mmol/l.A 2nd sample tube was also collected at the same time and the result from the c501 module was 61.8 mmol/l with a data flag.The auto repeat result on the c501 module was 69 mmol/l.A third sample was obtained on the same day and tested on the c501 module with a result of 57.8 mmol/l with a data flag.The auto repeat result on the c501 module was 63.1 mmol/l.The customer is wondering if the gluc3 assay is affected by a high ketone interference.The customer is also wondering if a high consumption of sucrose and fructose would interfere with the assay.The customer does not believe that the results from the radiometer blood gas analyzer are affected by high levels of sucrose and fructose.There was no allegation of an adverse event.The c501 module serial number was not provided.

Manufacturer Narrative

The customer thinks the results from the c501 module are correct.The customer was inquiring if a high concentration of ketones in the blood could cause an interference.Additional information was requested for investigation but was not provided.The reaction of the assay is highly specific and does not react with fructose-6-p, fructose-1,6-p2 or glucose-1p.

• Brand Name: GLUC3 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6574768
• MDR Text Key: 75419825
• Report Number: 1823260-2017-01027
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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: 04/27/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR