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 2017-02-22 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[68219388]
The customer contacted the siemens customer care center (ccc). The customer stated that the quality controls (qc) were within range on the day of the event. A siemens customer service engineer (cse) was dispatched to the customer site. The cse observed air bubbles in the degasser tubing and replaced the degasser. The cse repaired tubing connection and primed the system, which passed. The customer performed wash 2 test, which passed. The customer ran qc, which passed. The cause of the discordant, falsely elevated co2 results on three patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[68219389]
Discordant, falsely elevated carbon dioxide (co2) 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. It is unknown if the corrected 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 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00141 |
| MDR Report Key | 6350738 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-22 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-01 |
| Date Added to Maude | 2017-02-22 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD. (REGISTRATION # 3003637681) |
| Manufacturer Street | 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHS |
| Date Received | 2017-02-22 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-22 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-22 |