MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® CLINICAL CHEMISTRY XYSTEM; URINE OPIATES SCREEN FLEX® REAGENT CARTRIDGE

Catalog Number DF93A

Device Problem False Negative Result (1225)

Patient Problem Death (1802)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has determined that dimension urine opiate screen operated according to specification; siemens is filing this only to report a patient death at a subsequent treatment facility.The urine opiate screen detects morphine.Although heroin is metabolized to morphine, the concentration of morphine in urine may not be above the cut-off concentration (300 ng/ml) of the assay.As stated in the intended use of the dimension flex reagent cartridge urine opiates screen instructions for use: "opiates are absorbed rapidly.Heroin is converted almost immediately to morphine, which is excreted in urine both unchanged and as a glucuronidated metabolite.Excretion takes place over a period of a couple of days." naloxone was administered in the ambulance which indicates that they were following standard procedure for a heroin overdose; ongoing management of the patient would require titration of naloxone as needed to maintain breathing and consciousness.Additionally, the dimension urine opiates screen states in the instructions for use: "the opi method provides only a preliminary analytical test result.A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.Gas chromatography/mass spectrometry (gc/ms) is the preferred confirmatory method.Other chemical confirmation methods are available.Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used." diluting a urine sample and running the sample and multiplying by the dilution factor is non-standard use when the urine opiate screen is run in qualitative mode.Per the instructions for use, the dilution can only be used in the semi-quantitative mode.

Event Description

A patient was brought to the (b)(6) hospital facility by ambulance with a diagnosis of heroin overdose.The patient had been treated with naloxone by the paramedics.The patient was in cardiac arrest.While at the hospital, the patient's urine tested negative for opiates with the dimension urine opiates screen.The er transferred the patient to another hospital where he died.There was no indication that patient treatment would have been altered or prescribed on the basis of the negative opiates result.There was no indication that a medical procedure or a medical treatment was delayed on the basis of the negative opiates result.There is no allegation that harm to the patient or the death was due to the negative opiate result.

• Brand Name: DIMENSION® CLINICAL CHEMISTRY XYSTEM
• Type of Device: URINE OPIATES SCREEN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: edward szymanski ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026317672
• MDR Report Key: 4917271
• MDR Text Key: 22399649
• Report Number: 2517506-2015-00159
• Device Sequence Number: 1
• Product Code: DJG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/05/2016
• Device Catalogue Number: DF93A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR