MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GLUCOSE HK; HEXOKINASE, GLUCOSE

Catalog Number 04404483190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested for glucose hk (gluc3).The patient has paraplegia, has an infection and is hospitalized for exposed wounds and shows a positive blood culture.The patient is a diabetic and is being treated with meropenem.The customer wants to know if the meropenem could cause erroneous results for the gluc3 test.The erroneous results were reported outside of the laboratory.The initial gluc3 result from the c501 analyzer was 34 mg/dl.Two hours later a new sample was obtained and the result was 32 mg/dl from the c501 analyzer.At this time the patient began to have convulsions.The patient was tested on an accuchek active meter and the result was 35 mg/dl.The physician treated the patient with glucose intravenously.Twenty minutes later the patient was tested on the accuchek active meter with a result of 105 mg/dl and the intravenous glucose treatment was stopped.The samples were also sent to another laboratory where tests were run on an integra 400.The results from the integra 400 were similar to the results from the c501 analyzer.The physician decided to check the patient on the accuchek active meter because it was quicker and he believes the meropenem is interfering with the c501 results.One and a half hours later another sample was obtained and the result was 47 mg/dl from the c501 analyzer.The patient had normal results on the accuchek active meter between 80-100 mg/dl.The patient was tested again on the accuchek active meter and another handheld glucometer and the results were still between 80-100 mg/dl.On (b)(6) 2015 a sample from the patient on the c501 analyzer was between 30-40 mg/dl.The patient was tested on the accuchek active meter with results again between 80-100 mg/dl.No adverse event occurred due to the device.The patient is no longer being treated with meropenem.The patient remains in the hospital in stable condition.Additional results were provided from (b)(6) 2015 that were performed on the c501 analyzer of 53 mg/dl, 65 mg/dl, 173 mg/dl, and 177 mg/dl.The c501 analyzer serial number was (b)(4).Calibration and quality controls were acceptable.The customer indicated that until this event the results from the c501 analyzer normally correlate well with the accuchek active meter.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the data provided, reagent and hardware related issues could be excluded.

• Brand Name: GLUCOSE HK
• Type of Device: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5027773
• MDR Text Key: 24990839
• Report Number: 1823260-2015-04021
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• 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
• Event Location: Laboratory
• Date Manufacturer Received: 08/07/2015
• 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: 062 YR