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 2017-10-23 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[90784714]
The customer contacted the siemens customer care center (ccc). A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse performed total service visit on the instrument. The cse observed debris which appeared as a cloth material, partially aspirated into the plasma protein diluent (dpp) and hanging on the outside bottom of the sample probe. The cse cleared the debris and cleaned the probe. The cse checked all dispenses and ensured they were free of obstructed materials. The cse ran precision testing and quality control (qc), resulting within specification. The cause of the discordant, falsely low glucose result is associated with an obstructed probe caused by debris. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[90784715]
A discordant, falsely low glucose (glu) result was obtained on an advia 1800 instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate advia instrument, resulting higher. The repeated result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, low glu result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00565 |
| MDR Report Key | 6969295 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2000-04-17 |
| Date Added to Maude | 2017-10-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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, JA |
| Manufacturer Country | US |
| 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 | CFR |
| Date Received | 2017-10-23 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-23 |