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 2016-02-16 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[38287282]
The customer contacted the siemens customer care center (ccc). Ccc evaluated the customer's rf assay settings which were correct and dilution was correctly configured. A siemens headquarter support center (hsc) specialist evaluated the event data. Hsc determined that if a result is returned with "//////" flag this cannot be interpreted as high or low. The flag is a calculation error. When the flag is obtained along with a "j" flag, this indicates the value is above the absorbance of the highest calibrator standard and thus the value is greater than the analytical measurement range (amr). In addition, the only dilution ratio validated by siemens is 1:10. If the sample, after being automatically diluted by the system, is still off curve and greater than the amr, the assay can be manually diluted using saline. The customer has been trained on interpretations of flagged results. The cause of the customer reporting falsely low rf results to the physician(s) was a user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[38287283]
Two patient samples were tested on the advia 2400 instrument for rheumatoid factor (rf). The results were flagged by the instrument, indicating the results were above the analytical measurement range. The customer did not interpret the flags correctly and instead of repeating the samples, reported falsely low results for the two patients. The samples were repeated on the same instrument, resulting higher. It is unknown if the corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the falsely low rf results reported to the physician(s).
Patient Sequence No: 1, Text Type: D, B5
[42392924]
The initial mdr 2432235-2016-00082 was filed on february 16, 2016. Additional information (02/16/2016): in addition to the user error described initially, a siemens headquarter support center (hsc) specialist evaluated the event data. The issue was an incorrect laboratory information system (lis) configuration at the customer site. The lis sent new order requests to the system so the original order was removed. The system reacted as receiving a new order and ran the test as original instead of rerun with dilution. The system did flag appropriately with flags, indicating that the result was above the upper limit of linearity for the assay. The lis configuration was corrected and the account reports that the issue is resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00082 |
| MDR Report Key | 5439175 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-16 |
| Date of Report | 2016-01-21 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-02-16 |
| 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 | DHR |
| Date Received | 2016-02-16 |
| 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 | 2016-02-16 |
| 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 | 2016-02-16 |