MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY 10445389 manufactured by Siemens Healthcare Diagnostics Inc.
[77554004]
Siemens healthcare diagnostics inc. (siemens) headquarters support center concluded that the cause of the discordant tricyclic antidepressant (tca) result on the urine survey sample was due to the operator running the tca as user defined method (udm). Based on the (b)(6) report provided by the operator, the use of methodology eia and 1000 ng/ml cutoff for this sample was graded as non-consensus. The syva emit tox serum tricyclic antidepressant assay was validated by siemens to be used with human or serum with a 300 ng/ml cutoff for serum. The operator is running this assay with urine patient samples, urine survey samples, and urine controls with a 1000ng/ml cutoff, which is a serum calibrator. According to the syva emit tox serum tricyclic antidepressants assay's instruction for use (ifu), "user defined modifications are not supported by siemens as they may affect performance of the system and assay results. It is the responsibility of the user to validate modifications to these instructions or use of the reagents on analyzers other than those included in siemens application sheets or these instructions for use". The user did not follow product instructions in the instruction for use, resulting in the cap failure and potential harm to the user or potential erroneous patient results. The instrument and the reagents used are performing according to specifications. No further evaluation of this device or reagent is required.
Patient Sequence No: 1, Text Type: N, H10
[77554005]
An operator failed the (b)(6) survey with user defined method (udm) tricyclic anti-depressants (tca) on march 21, 2017. The operator reported that they selected the methodology as eia 1000 for cutoff for tricyclic group. The urine survey sample was spiked with 2000 ng/ml of doxepin and based on the syva emit tox serum tricyclic antidepressants assay's instruction for use (ifu), a concentration of 500 ng/ml of doxepin should show a positive response at the 300 ng/ml cutoff in serum or plasma sample. The operator obtained and reported a discordant negative result on this sample for tricyclic group. After obtaining the failure report, the operator re-ran calibration and controls and claimed that the calibration and controls recovered within acceptable ranges. The operator removed the same urine survey sample from the refrigerator and re-ran the survey sample. The operator obtained a negative result again. The operator is running this tca assay with urine samples, urine survey samples and urine controls with a 1000ng/ml cutoff, which is a serum calibrator. The operator claims that he has been reporting patient tca results to physician and they have not questioned the results. This survey failure did not cause a delay. The laboratory continued to run patient samples. There are no known reports of patient intervention or adverse health consequences. The operator has indicated that the issue is only related to discordant cap survey results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00532 |
| MDR Report Key | 6637583 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-05-20 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-06-13 |
| 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 | 3 |
| Manufacturer Contact | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY |
| Generic Name | SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSAY |
| Product Code | LFG |
| Date Received | 2017-06-13 |
| Model Number | SYVA EMIT TOX SERUM TRICYCLIC ANTIDEPRESSANTS ASSA |
| Catalog Number | 10445389 |
| Lot Number | K1 |
| Device Expiration Date | 2019-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |