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 2017-06-30 for ADVIA 120/2120/2120I DIFF TIMEPAC 10312270 manufactured by Siemens Healthcare Diagnostics Inc..
[78815851]
Siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to determine the cause of the leak from the advia 120 hematology system with autosampler. Siemens customer service engineer (cse) replaced the connector to the sheath filter and replaced locking washer. The system was fully functional upon the cse departure. Siemens determined that the operator's finger was exposed to the advia 120/2120/2120i diff timepac (diff timepac) reagents because she was not wearing personal protective equipment (ppe). The advia diff timepac safety data sheet (sds) states to "wear protective gloves/protective clothing/eye protection/face protection" prior to handling diff timepac reagents. The instrument and the reagents are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[78815852]
An operator noticed that the advia 120/2120/2120i diff timepac (diff timepac) reagent leaked from the advia 120 hematology system with autosampler prior to performing the baso chamber backflush procedure on the instrument. The operator's finger accidentally came in contact with the diff timepac reagent. The operator was not wearing personal protective equipment (ppe) when she was exposed to the leaking diff timepac reagent. The operator did not seek medical intervention. There are no known reports of adverse health consequences due to the operator's exposure to the diff timepac reagent on the advia 120 hematology system with autosampler.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00400 |
| MDR Report Key | 6680029 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-06-30 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | THERMO FISHER SCIENTIFIC |
| Manufacturer Street | 8365 VALLEY PIKE REGISTRATION # 1181121 |
| Manufacturer City | MIDDLETOWN VA 22645 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22645 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120/2120/2120I DIFF TIMEPAC |
| Generic Name | ADVIA 120/2120/2120I DIFF TIMEPAC |
| Product Code | GKL |
| Date Received | 2017-06-30 |
| Model Number | ADVIA 120/2120/2120I DIFF TIMEPAC |
| Catalog Number | 10312270 |
| Lot Number | 59225 |
| Device Expiration Date | 2018-05-31 |
| 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 | 2017-06-30 |