MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for CHEMISTRY CALIBRATOR (CHEM CAL) manufactured by Siemens Healthcare Diagnostics Inc..
[105675893]
A siemens headquarter support center (hsc) specialist reviewed the information in the complaint. There was no patient diagnosis information associated with these results. There was not enough information provided to determine if the bias or change in recovery is due to change in diagnosis, patient condition, change in calibrator lot, reagent lot or instrument performance. The cause of the discordant, falsely depressed creatinine results is unknown. Advia chemistry calibrator lot 135808 is performing as intended. No further evaluation of the device is required. Mdr 2432235-2018-00151 was filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[105675894]
Discordant, falsely depressed creatinine (enzymatic method) results were obtained on the advia chemistry enzymatic creatinine_2 (ecre_2) assay. The discordant result was obtained after the assay was calibrated using a new lot of calibrator. The discordant results was not in alignment with previous results of the samples. It is not known if any of the discordant results were reported to physician(s). There are no known reports of patient intervention due to the discordant creatinine results. There are no known reports of a delay in administering treatment or medical intervention to the patients due to the discordant creatinine results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00152 |
| MDR Report Key | 7426996 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-05-28 |
| Date Added to Maude | 2018-04-12 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | THERMO FISHER SCIENTIFIC |
| Manufacturer Street | REGISTRATION # 1181121 8365 VALLEY PIKE |
| Manufacturer City | MIDDLETOWN VA 22645 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22645 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHEMISTRY CALIBRATOR (CHEM CAL) |
| Generic Name | CHEMISTRY CALIBRATOR (CHEM CAL) |
| Product Code | JIX |
| Date Received | 2018-04-12 |
| Model Number | CHEMISTRY CALIBRATOR (CHEM CAL) |
| Lot Number | 135808 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |