MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for EMIT 2000 GENTAMICIN PLUS ASSAY 10445333 manufactured by Siemens Healthcare Diagnostics Inc..
[73379011]
Siemens healthcare diagnostics regional support center (rsc) investigated the cause of the discordant, elevated gentamicin result on the viva-e analyser instrument. The cause of the discordant high gentamicin result was due to running a sample containing low levels of gentamicin following a sample containing elevated levels of gentamicin. The customer was running 20 samples and processed the affected sample after processing another patient sample having an extremely high gentamicin value (165. 0 ug/ml). The gentamicin plus assay application sheet demonstrates that this circumstance can potentially cause carryover. Siemens rsc provided the information from the gentamicin application sheet, which the customer already had access to and which states: "carryover can occur with this assay when a negative sample or a sample containing low levels of gentamicin is assayed following a sample containing elevated levels of drug". Siemens attempted to obtain the lot number and expiration date of the affected gentamicin reagent and the customer has refused to provide the information. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[73379012]
A discordant, falsely elevated gentamicin result was obtained on a patient sample on the viva-e analyser instrument. This result was provided to the physician, who questioned the result. The same patient sample was repeated the next day on the same viva-e analyser instrument and recovered within the expected patient range. The re-run result was reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated gentamicin result.
Patient Sequence No: 1, Text Type: D, B5
[96241113]
Siemens healthcare diagnostics inc. Filed the initial mdr (2517506-2017-00409) on april 19, 2017. June 16, 2017 corrected information: the information provided in manufacturer info in the original mdr is incorrect and this part has been updated to reflect the correct information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00409 |
| MDR Report Key | 6504523 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-06-16 |
| Date Added to Maude | 2017-04-19 |
| 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 105916101 |
| Manufacturer Country | US |
| Manufacturer Postal | 105916101 |
| 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 | 3 |
| Brand Name | EMIT 2000 GENTAMICIN PLUS ASSAY |
| Generic Name | EMIT 2000 GENTAMICIN PLUS ASSAY |
| Product Code | LCD |
| Date Received | 2017-04-19 |
| Model Number | EMIT 2000 GENTAMICIN PLUS ASSAY |
| Catalog Number | 10445333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-04-19 |