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 2017-02-16 for ADVIA CHEMISTRY FERRITIN REAGENTS (FRT) 10494078 manufactured by Siemens Healthcare Diagnostics Inc..
[67545100]
The customer contacted a siemens customer care center and stated that their quality controls were within acceptable range. A siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated that there was no reagent issue. The hsc specialist determined that the discordant results were consistent with interference. As per the limitations section of advia chemistry ferritin instructions for use, "as with any chemical reaction, you must be alert to the possible effect on results of unknown interferences from medications or endogenous substances. The laboratory and physician must evaluate all patient results in light of the total clinical status of the patient. " the cause of interference on the patient sample is unknown. The device is performing as expected. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[67545101]
The customer obtained discordant, falsely low ferritin (frt) results upon initial and repeat testing on one patient sample when tested on two advia 2400 instruments, while using reagent lot 380707. The customer diluted the sample and ran it on an alternate platform where the results were higher. A new sample was obtained from the same patient and it was tested on the advia 2400 instrument and the alternate platform. The result obtained on the advia 2400 was still low, while that on the alternate platform was higher. There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely low frt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00110 |
| MDR Report Key | 6335203 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-16 |
| Date of Report | 2017-02-16 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | REGISTRATION # 8020890 55 DIAMOND ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY FERRITIN REAGENTS (FRT) |
| Generic Name | ADVIA CHEMISTRY FERRITIN REAGENTS (FRT) |
| Product Code | DBF |
| Date Received | 2017-02-16 |
| Model Number | ADVIA CHEMISTRY FERRITIN REAGENTS (FRT) |
| Catalog Number | 10494078 |
| Lot Number | 380707 |
| 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 | 2017-02-16 |