MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-01-29 for ADVIA 1650 073-A001 manufactured by Siemens Healthcare Diagnostics Inc..
[1418568]
A lethargic and somewhat unresponsive patient was admitted to the er on (b) (6) 2010. The lab ran an advia 1800 phenytoin on the patient sample obtained a result of /////. The lab manually reported a result of < 0. 8 back to the er. The patient was admitted to the hospital where she was treated with two forms of dilantin. The lab ran blood samples from the patient from (b) (6) 2010-(b) (6) 2010 and the lab reported phenytoin results for all samples as < 0. 8. They had continued to medicate the patient assuming that the patient was a 'high metabolizer". An overnite technologist diluted the sample for unknown reasons and obtained toxic results phenytoin results over 100 ug/ml. The patient is being monitored for possible harm.
Patient Sequence No: 1, Text Type: D, B5
[8344221]
The customer had manually reported the phenytoin results out as < 0. 8 when the advia 1800 reported results as /////. Siemens instruction for interpretation of therapeutic drug methods is clearly outlined in a customer bulletin, which states that the software will display a calculation error (/////) instead of a result if a valid result cannot be calculated based on the calibration curve fit and calculation method. The software does not display any indication that the result is below the range or above the range for the method. Siemens customer bulletin specifically states: "regardless, interpret a calculation error (/////) as an unreportable result. " the advia 1800 operator's guide also explains the flag displayed for calculation errors. Customer error caused the event. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[18274581]
Corrected information: it was determined that the system involved in this event was an advia 1650, with serial number as noted.
Patient Sequence No: 1, Text Type: D, B5
[18519798]
Siemens filed the initial mdr on 1/29/2010. Corrected information 6/18/2012: siemens recently became aware that the instrument associated with this event was an advia 1650, not an advia 1800. The corrections have been noted in this report.
Patient Sequence No: 1, Text Type: N, H10
[26377730]
The initial mdr 2432235-2010-00022 was filed on january 29, 2010. Additional information (12/04/2013): siemens healthcare diagnostics has investigated the incidents of slashmarks being reported as numerical patient results. Urgent medical device correction (umdc) 10816024 was sent to customers in the united states and urgent field safety notice (ufsn) 10816023 was sent to customers outside the united states. The umdc/ufsn is entitled "advia 1200 and advia 1650 ///// overflow flag misinterpretation," and explains that the slashmarks are displayed when a result cannot be calculated or the concentration of a test is outside the absorbance limits. The umdc/ufsn instructs customers not to interpret slashmarks as a concentration or as an above or below assay range flag, not to edit the slashmarks, and not to report slashmarks as patient results. In addition, a siemens customer service engineer will afix a label stating, "///// = error (invalid result). Do not edit or report ///// as a result. " several customer bulletins have previously been sent to customers alerting them that a slashmark result is unreportable. Additionally, the online help indicates that a slashmark flag represents an overflow, which is a calculation error. The patient has sustained permanent impairment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2010-00022 |
| MDR Report Key | 1592498 |
| Report Source | 05,06 |
| Date Received | 2010-01-29 |
| Date of Report | 2010-01-23 |
| Date of Event | 2010-01-19 |
| Date Mfgr Received | 2013-12-04 |
| Date Added to Maude | 2010-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | 3-1-2- MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-12/13/13-012-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1650 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2010-01-29 |
| Model Number | ADVIA 1650 |
| Catalog Number | 073-A001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2010-01-29 |