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 2017-05-09 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[74791433]
The customer contacted the siemens customer care center and stated that their quality controls and calibrations were within acceptable range. A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse suspected the issue to be contamination. The cse cleaned the reagent containers, replaced the fluids pertaining to co2, primed the lines and performed precision testing. During a follow-up visit, the cse performed decontamination and ran quality controls and calibrations, which were acceptable. The customer did not obtain additional discordant results. The cause of the discordant, falsely elevated co2 result 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
[74791434]
A discordant, falsely elevated concentrated carbon dioxide (co2_c) result was obtained on one patient sample on an advia 1800 instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate advia chemistry instrument, resulting lower. The result obtained from 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 elevated co2_c result.
Patient Sequence No: 1, Text Type: D, B5
[78167634]
The initial mdr 2432235-2017-00296 was filed on may 9, 2017. The method affected was concentrated carbon dioxide. The correct method is liquid carbon dioxide (co2_l).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00296 |
| MDR Report Key | 6555186 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-09 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-05-09 |
| 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. (REGISTRATION # 3003637681) |
| Manufacturer Street | 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 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHS |
| Date Received | 2017-05-09 |
| Model Number | ADVIA 1800 |
| 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 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-09 |
| Model Number | ADVIA 1800 |
| 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 | 2017-05-09 |