MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT 10341115 manufactured by Siemens Healthcare Diagnostics Inc..
[25887733]
Siemens customer care center (ccc) has notified the customer that the advia chemistry total bilirubin_2 assay has not been validated with neonatal samples and is not approved by the fda for testing with neonatal samples. The customer informed ccc that they were aware of this claim. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[25887734]
The customer is running neonatal samples for total bilirubin_2 (tbil_2) on an advia chemistry 1800 instrument. A neonatal sample run on the advia chemistry 1800 instrument gave a discordant result and the infant was hospitalized. After admission to the hospital the test was repeated again on the patient (new blood draw) and was within the expected range. The repeat result was reported to the physician(s) and was acceptable. There were no reports of adverse health consequences due to the discordant result for total bilirubin on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00386 |
| MDR Report Key | 5057461 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-08-31 |
| Date Added to Maude | 2015-09-04 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 2517506) |
| Manufacturer Street | 500 GBC DRIVE P.O BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT |
| Generic Name | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT |
| Product Code | JFM |
| Date Received | 2015-09-04 |
| Model Number | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 REAGENT |
| Catalog Number | 10341115 |
| Lot Number | 327280 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |