MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-10 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[26650187]
The customer contacted a siemens customer care center (ccc) specialist. The customer required information about what was in the level 4 quality control material. The ccc specialist informed the customer that as per (b)(6) instructions for use, "the level 4 quality control material is biohazardous and the material should be treated as potentially infectious. The operator should handle this product according to the established good laboratory practices and universal precautions". The cause of the quality control material being splashed on the customer's face was related to the customer not wearing eye protection. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[26650188]
The operator of an advia centaur xp was splashed in the face with the enhanced (b)(6) level 4 quality control (qc) material while performing a calibration. The customer rinsed and washed her face. The customer was wearing a lab coat and the gloves but was not wearing eye protection. The customer is not sure if the material went into her eyes. The customer went to an emergency room where her eyes were checked and collected a blood sample to follow-up with the exposure protocol. There are no known reports of patient intervention or adverse health consequences due to quality control material being splashed on the customer's face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00397 |
| MDR Report Key | 5069574 |
| Date Received | 2015-09-10 |
| Date of Report | 2015-08-17 |
| Date of Event | 2015-08-17 |
| Date Mfgr Received | 2015-08-17 |
| Device Manufacturer Date | 2014-09-22 |
| Date Added to Maude | 2015-09-10 |
| 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, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | NHS |
| Date Received | 2015-09-10 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-10 |