MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-19 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[36350965]
The customer contacted the siemens customer care center (ccc). After obtaining imprecise afp results on one patient sample, the customer ran precision on level 2 quality controls (qc) and results were imprecise. The ccc specialist instructed the customer to perform a precision test on a new afp reagent pack. The customer replaced the afp reagent pack with a pack from a new reagent lot and calibrated. Level 1 and level 3 qc were out of range high. A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse performed a total service visit. The cse reviewed the most recent calibration data, ran a new calibration and qc. During follow-up with the customer, the customer stated that there have not been any further issues with imprecision and qc had been within range. The cause of the imprecise afp results on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[36350966]
Imprecise alpha-fetoprotein (afp) results were obtained on one patient sample on an advia centaur xp instrument. The customer did not report any of the results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the imprecise afp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00034 |
| MDR Report Key | 5377629 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-19 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-12-22 |
| Date Mfgr Received | 2015-12-22 |
| Device Manufacturer Date | 2010-01-18 |
| Date Added to Maude | 2016-01-19 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2016-01-19 |
| Model Number | ADVIA CENTAUR XP |
| 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 CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-01-19 |
| Model Number | ADVIA CENTAUR XP |
| 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 | 2016-01-19 |