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 2017-09-28 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[89426492]
A siemens field application specialist (fas) was dispatched to the customer site. The fas determined that the customer had obtained a new sample ((b)(6)) from the patient and ran it on the same instrument for troubleshooting purpose, which resulted higher than the initial result and matched the repeat result obtained on the original sample. The fas checked both samples visually and neither of samples exhibited signs of fibrin or clots. The samples were properly centrifuged and clear of hemolysis/icterus/lipemia. The event log did not show any indication of processing error. However, there was a "9188 check the rvts" error (vacuum tank error) prior to sample processing. No other samples from same time frame showed any similar discrepancy. A siemens customer service engineer (cse) was dispatched to the customer site. The cse checked the probe alignment and determined that the sample dilution probe (dpp) was touching the edge of the dilution tray cuvettes. The cse replaced the dpp and the customer checked the alignments and washing. The cause of the discordant, falsely low co2_c result on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
[89426493]
A discordant, falsely low concentrated carbon dioxide (co2_c) result was obtained on one patient sample on an advia 1800 instrument. The initial result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low co2_c result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00527 |
| MDR Report Key | 6902363 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-28 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-09-28 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| 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 | 2017-09-28 |
| 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 | 2017-09-28 |
| 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 | 2017-09-28 |