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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® CLINICAL CHEMISTRY XYSTEM URINE OPIATES SCREEN FLEX® REAGENT CARTRIDGE Back to Search Results
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.

 
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Brand NameDIMENSION® CLINICAL CHEMISTRY XYSTEM
Type of DeviceURINE 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 Key4917271
MDR Text Key22399649
Report Number2517506-2015-00159
Device Sequence Number1
Product Code DJG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK003209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2015
Is This A Product Problem Report? Yes
Device Operator MEDICAL TECHNOLOGIST
Device EXPIRATION Date02/05/2016
Device Catalogue NumberDF93A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/05/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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