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 2017-02-20 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[68011350]
The customer contacted a siemens customer care center and stated that the relative light unit for calibration run was different on the day discordant results were obtained. The customer also stated that the acid and base were at slightly different levels. They had replaced the acid and base solutions individually at different times. Quality controls on (b)(6) 2017 were within range, while on (b)(6) 2017 quality controls were out of range. The customer performed recalibration on (b)(6) 2017 and reran quality controls and patient samples, which were acceptable. A siemens customer service engineer (cse) was dispatched to the customer site. The cse performed a total service call and checked the reagent probe dispense volumes and acid and base volumes. The cse ran aspirate and dispense tests and dark counts, which were acceptable. The instrument data showed that the relative light unit for calibration run was low on (b)(6) 2017 and came to the nominal on single reagent pack. The current calibration was acceptable and other assays with the same wash sequence were running without issue. The cse ran quality control and performed precision testing, which were acceptable. The cause of the discordant, falsely low prge results on multiple patient samples is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[68011351]
Discordant, falsely low progesterone (prge) results were obtained on multiple patient samples on an advia centaur xp instrument. The discordant results were reported to the physician(s). After performing recalibration, the customer repeated the patient samples on the same instrument, which resulted higher. The corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low prge results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00132 |
| MDR Report Key | 6342898 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-20 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-01-25 |
| Date Mfgr Received | 2017-01-26 |
| Device Manufacturer Date | 2014-01-13 |
| Date Added to Maude | 2017-02-20 |
| 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 | JLS |
| Date Received | 2017-02-20 |
| 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 | 2017-02-20 |
| 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 | 2017-02-20 |