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 2017-06-22 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[78259450]
A siemens customer service engineer (cse) was dispatched to the customer site. The customer stated that the instrument produced dilution tray overflow errors on the day discordant result was obtained. The cse reviewed the instrument data and determined there were multiple patient results with negative values. The cse checked the reaction tray washer and dilution washer for overflows and completed wash 2. The cause of the discordant, falsely low aat results on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[78259452]
A discordant, falsely low alpha-1-antitrypsin (aat) result was obtained on one patient sample on an advia 2400 instrument. The initial result was reported to the physician(s), who questioned it. The sample was repeated on an alternate advia chemistry instrument, resulting higher and matching the clinical picture of the patient. A new sample tube was obtained from the patient and was run on the alternate advia chemistry instrument, also resulting higher. The corrected result obtained from the new sample tube on the alternate advia chemistry instrument was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low aat result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00380 |
| MDR Report Key | 6661572 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-22 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-05-27 |
| Date Mfgr Received | 2017-07-07 |
| Device Manufacturer Date | 2008-09-04 |
| Date Added to Maude | 2017-06-22 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 96-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 96-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | DEM |
| Date Received | 2017-06-22 |
| Model Number | ADVIA 2400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JJE |
| Date Received | 2017-06-22 |
| Model Number | ADVIA 2400 |
| 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 | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-22 |