MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-17 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[72947397]
The customer contacted a siemens customer care center (ccc). Calibration and quality controls on the day of event occurrence were within acceptable range. A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse found a clog in the reaction cuvette washer probe 2 and repaired it. The cse performed wash 2 rinse sequence and ran quality controls, which were acceptable. The cause of the discordant, falsely elevated co2_l results on three patient samples is unknown. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[72947398]
Discordant, falsely elevated liquid carbon dioxide (co2_l) results were obtained on three patient samples on an advia 1800 instrument. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument, resulting lower and matching the historical results of the patients. The repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated co2_l results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00262 |
| MDR Report Key | 6497432 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2008-06-17 |
| Date Added to Maude | 2017-04-17 |
| 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 #: 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | CHS |
| Date Received | 2017-04-17 |
| Model Number | ADVIA 1800 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | JJE |
| Date Received | 2017-04-17 |
| Model Number | ADVIA 1800 |
| 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 | 2017-04-17 |