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 2017-02-03 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[66499038]
The customer contacted the siemens customer care center (ccc) and reported a reagent probe 1 (r1) splatter issue. A siemens customer service engineer (cse) was dispatched to the customer site. The cse performed r1 wash port alignment and cleaned r1. The cse performed several barcode scans with no splash. The cse ran quality controls (qc), which within acceptable limits. The cause of the discordant, falsely elevated albp result on a patient sample 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
[66499039]
A discordant, falsely elevated albumin bcp (albp) result was obtained on a patient sample on an advia 2400 instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate advia 2400 instrument, resulting lower. It is unknown if the corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated albp result.
Patient Sequence No: 1, Text Type: D, B5
[73366152]
The initial mdr 2432235-2017-00098 was filed on february 3, 2017. Additional information (02/28/2017): a siemens headquarters support center (hsc) specialist reviewed the service report. The hsc specialist stated that the wash port for the reagent 1 probe was not properly aligned and therefore the probe was not getting an adequate wash which could cause carryover and impact results. The issue was resolved with service intervention.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00098 |
| MDR Report Key | 6300513 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-03 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-02-28 |
| Date Added to Maude | 2017-02-03 |
| 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 |
| 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 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-02-03 |
| Model Number | ADVIA 2400 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-03 |
| Model Number | ADVIA 2400 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-03 |