MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-01-08 for SYVA EMIT 6L119UL manufactured by Dade Behring, Inc..
[560471]
A falsely depressed methotrexate result of 0. 3 umol/l was obtained on a patient sample. The result was reported to the physician. The sample was repeated and a result of 2. 6 uml/l was obtained. The pt developed liver problems, but it is unknown if it was because of the falsely depressed methotrexate or other drugs that the patient was taking. Instrument data indicates that the falsely depressed methotrexate was non standard use of the assay. There is not an approved protocol for the use of the methotrexate assay on the dimension instrument line.
Patient Sequence No: 1, Text Type: D, B5
[7937602]
No further evaluation of the device is required. Instrument data indicates that the falsely depressed methotrexate was non standard use of the assay. There is not an approved protocol for the use of the methotrexate assay on the dimension instrument line. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2917681-2007-00001 |
| MDR Report Key | 810119 |
| Report Source | 05 |
| Date Received | 2007-01-08 |
| Date of Report | 2006-12-14 |
| Date of Event | 2006-12-01 |
| Date Mfgr Received | 2006-12-14 |
| Date Added to Maude | 2007-01-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROLYN CHASTAIN |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318789 |
| Manufacturer G1 | DADE BEHRING, INC. |
| Manufacturer Street | 20400 MANANI AVE |
| Manufacturer City | CUPERTINO CA 95014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95014 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYVA EMIT |
| Generic Name | EMIT METHOTREXATE ASSAY |
| Product Code | LAO |
| Date Received | 2007-01-08 |
| Model Number | NA |
| Catalog Number | 6L119UL |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 797603 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 20400 MANANI AVE. CUPERTINO CA 95014 US |
| Baseline Brand Name | SYVA EMIT |
| Baseline Generic Name | EMIT METHOTREXATE ASSAY |
| Baseline Model No | NA |
| Baseline Catalog No | 6L119UL |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-08 |