MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-08 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[59571431]
The customer contacted a siemens customer care center (ccc) specialist and stated that they ran syva emit 2000 tacrolimus a third party assay on the advia chemistry xpt instrument. Quality controls and patient results were low on kit lot j1. The customer repeated the patient samples on kit lot h2 and obtained acceptable results. A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer and stated that the syva emit 2000 tacrolimus reagent has not been validated or approved by siemens for use on the advia chemistry xpt instrument. The issue represents a non-standard use of syva emit 2000 tacrolimus reagent. Advia chemistry xpt instrument is performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
[59571432]
Discordant, falsely low tacrolimus results were obtained on multiple patient samples on an advia chemistry xpt instrument. The discordant results were not reported for sample ids (b)(6) to the physician(s). The samples were repeated using a different kit lot (lot h2), resulting higher and matching the clinical picture of the patients. The repeat results were reported for sample ids (b)(6) to the physician. It is unknown if the initial or repeat results were reported for the rest of the samples. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low tacrolimus results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00687 |
| MDR Report Key | 6087359 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-08 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2016-10-10 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2016-11-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER:3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MLM |
| Date Received | 2016-11-08 |
| Model Number | ADVIA CHEMISTRY XPT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-11-08 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-08 |