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 2016-08-17 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[52391802]
The customer contacted the siemens customer care center (ccc). Ccc sent the customer a replacement reagent with a new lot; however the issue was not resolved. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[52391803]
The operator of an advia 2400 instrument reported a salicylate result of 29. 6 mg/l. When the sample was repeated; a negative value result was obtained. The customer recalibrated the method and reran patient samples previously reported, and results differed upon repeat testing. Corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant salicylate results.
Patient Sequence No: 1, Text Type: D, B5
[57588967]
The initial mdr 2432235-2016-00488 was filed on august 17th, 2016. Additional information (08/31/2016): sample ids were provided for the results included in the initial report. A siemens headquarter support center (hsc) specialist evaluated the event data. Upon further investigation, the applications specialist found the customer is reporting in mg/l and not the standard mg/dl units. The standard units for salycilate per the instructions for use (ifu) are mg/dl. If the analytical measuring range (amr) of 3. 0 mg/dl - 100 mg/dl is translated to mg/l then the amr would be 30 mg/l - 1000 mg/l. The samples showing the imprecision were under 30 mg/l and thus are below the amr and siemens does not have precision or accuracy claims below the amr. The samples being tested are outside of the defined usage of this assay on the advia 2400 instrument. Reporting these samples would be considered non-standard usage by siemens. Instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00488 |
| MDR Report Key | 5884661 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-17 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-07-16 |
| Date Mfgr Received | 2016-08-31 |
| Date Added to Maude | 2016-08-17 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER:3003637681 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 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKJ |
| Date Received | 2016-08-17 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-08-17 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-17 |