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 2017-09-29 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[87874655]
The customer contacted the siemens customer care center (ccc) to report the discordant uric acid concentrated (ua_c) result. Ua_c was an add-on test for sample id (b)(6). The sample had initially resulted lower and was auto repeated from dilution turntable (dtt), also resulting lower. Calibration was within acceptable range. The customer inspected the probes and checked quality control (qc), which were acceptable. The customer suspected that the issue was due to a fibrin or a clot in the sample. A siemens headquarters support center (hsc) specialist reviewed the information provided and does not suspect reagent or instrument issues. Qc recovery were within expected range. The information provided and the data is consistent with the sample specific issues with the potential cause being integrity of the sample. The add-on ua_c and the auto repeat result were sampled for the dilution turntable (dtt) cuvette and both results matched, indicating possible cellular debris, fibrin, or clots in the primary sample used to provide sample for the dtt. The cause of the discordant ua_c result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[87874656]
Discordant, falsely low uric acid concentrated (ua_c) results were obtained upon initial and repeat testing on one patient sample on an advia 2400 instrument. The discordant results were reported to the physician(s), who questioned them. The sample was repeated on an alternate instrument, resulting higher. The corrected result was reported to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ua_c results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00532 |
| MDR Report Key | 6905994 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-07 |
| Date Added to Maude | 2017-09-29 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | 3-1-2 MUSASHINO AKISHIMA REGISTRATION#: 3003637681 |
| 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 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | CDO |
| Date Received | 2017-09-29 |
| Model Number | ADVIA 2400 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JJE |
| Date Received | 2017-09-29 |
| Model Number | ADVIA 2400 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-29 |