MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-15 for DIMENSION? CLINICAL CHEMISTRY XYSTEM DF93A manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[22399649]
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.
Patient Sequence No: 1, Text Type: N, H10
[22399650]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2015-00159 |
| MDR Report Key | 4917271 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-29 |
| Date Mfgr Received | 2015-06-30 |
| Device Manufacturer Date | 2015-02-05 |
| Date Added to Maude | 2015-07-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY XYSTEM |
| Generic Name | URINE OPIATES SCREEN FLEX? REAGENT CARTRIDGE |
| Product Code | DJG |
| Date Received | 2015-07-15 |
| Catalog Number | DF93A |
| Device Expiration Date | 2016-02-05 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-15 |