MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-04 for ADVIA CENTAUR PHENYTOIN (PHTN) 08765276 manufactured by Siemens Healthcare Diagnostics.
[1072481]
Discrepant advia centaur phenytoin results were obtained on a pt sample. The results were reported to the doctor. The technician questioned initial results from sample in serum separator tube (sst) and subsequently ran a sample from a red top tube. A corrected report was issued. The customer does not know of any report of pt intervention or adverse health consequences due to the discrepant phenytoin results.
Patient Sequence No: 1, Text Type: D, B5
[8177457]
Initial incorrect results were obtained when a serum separator tube (sst) was used. Siemens advia centaur assay manual (b)(4) for phenytoin (phtn) specifically states: "available literature references present conflicting and complex recommendations on the use of gel barrier tubes for therapeutic drug monitoring samples. Each lab should contact their specific tube manufacturer for additional info and recommendations for therapeutic drug monitoring testing with the advia centaur systems. Serum, heparinized plasma, or edta plasma are the recommended sample types for this assay. " the subsequent use of a "red top" sample yielded correct results. The customer refused a service call. The instrument is performing within specifications. No further eval of the service is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2009-00024 |
| MDR Report Key | 1334964 |
| Report Source | 05,06 |
| Date Received | 2009-03-04 |
| Date of Report | 2009-02-20 |
| Date of Event | 2009-02-19 |
| Date Mfgr Received | 2009-02-20 |
| Date Added to Maude | 2010-08-27 |
| 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 | EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY ST. |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY ST. |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR PHENYTOIN (PHTN) |
| Generic Name | PHENYTOIN IMMUNOASSAY |
| Product Code | LGR |
| Date Received | 2009-03-04 |
| Model Number | NA |
| Catalog Number | 08765276 |
| Lot Number | 178 |
| ID Number | NA |
| Device Expiration Date | 2009-10-31 |
| 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 |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-04 |