MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-22 for DIMENSION? CLINICAL CHEMISTRY SYSTEM 6L119UL manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[18271554]
A group of discrepant elevated methotrexate results was obtained on multiple samples from an individual patient. The results were reported to the physician who questioned the results. The samples had been run and results reported on dilutions contrary to instructions for use directions. It is unknown if patient treatment was altered as a result of the discrepant elevated methotrexate results. There was no report of adverse health consequences as a result of the discrepant elevated methotrexate results.
Patient Sequence No: 1, Text Type: D, B5
[18460948]
Analysis of the instrument and instrument data indicates that the cause for the discrepant elevated methotrexate reported result is user error (non-standard use). The account performed dilutions as prescribed in the methotrexate ifu but reported result of dilutions beyond the minimal dilution that provided the first unflagged results which would provide the appropriate result. The instructions for use for the methotrexate assay contains the following information: the emit methotrexate assay can be used to analyze samples containing 0. 3-2600 umol/l methotrexate, quantitation of concentrations less than 0. 3 umol/l is not recommended. Patient samples and calibrators containing 0. 3 - 2 umol/l methotrexate are assayed according to the primary protocol. Samples containing more than 2 umol/l methotrexate can be brought within the range of the standard curve by using a calibrated pipette to serially dilute them 1:6 with buffer solution. Additionally it states: when a value for the specimen is between 0. 3 and 2 umol/l, multiply the observed value by the corresponding adjustment factor for the tube. Additionally it states: a serum methotrexate concentration above 5 umol/l at 24 hours after high dose therapy generally indicates a risk of toxicity. The account uses a non-standard practice of diluting all samples with the secondary protocol regardless if the original undiluted sample gave a result within the 0. 3 to 2 umol/l assay range. In the case of the 8am (b)(6) 2014 sample, the account reported a discrepant elevated result from a dilution above the true value which should have been reported from the undiluted sample. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2014-00363 |
| MDR Report Key | 4349343 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-04 |
| Date of Event | 2014-12-03 |
| Date Mfgr Received | 2014-12-04 |
| Date Added to Maude | 2015-01-07 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| 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 | 3 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | METHOTREXATE ASSAY |
| Product Code | LAO |
| Date Received | 2014-12-22 |
| Catalog Number | 6L119UL |
| Lot Number | NOT PROVIDED |
| 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 | 2014-12-22 |