MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-01-04 for IMMULITE 1000 VITAMIN B12 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[132629421]
Siemens investigated the event and determined the operator did not follow the instructions in the immulite/immulite 1000 vitamin b12 instructions for use, which instructs the user to use extreme care to avoid all bodily contact with this reagent, due to the presence of cyanide. In addition, the safety data sheet indicates the individual protection measures for skin protection when using this product. The operator was not wearing personal protective equipment (ppe) when using the vitamin b12 borate kcn buffer solution. The cause of the event was due to the operator not following the instructions in the instructions for use or the safety data sheets. No further evaluation of the device is required. The system is performing within manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
[132629422]
Siemens was informed that while using the vitamin b12 borate kcn buffer solution, 20-30 ml of the buffer spilled on the operator's legs. The operator's skin was red at the site of the buffer contact area but faded after a short period of time. The customer informed siemens that the operator was wearing gloves at the time of use. The operator consulted a physician(s). It is unknown if any medical treatment was rendered. There was no report of adverse health consequences due to the spill of the buffer solution on the operator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2019-00003 |
| MDR Report Key | 8217112 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2019-01-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 1000 VITAMIN B12 |
| Generic Name | IMMULITE 1000 VITAMIN B12 |
| Product Code | LIG |
| Date Received | 2019-01-04 |
| Model Number | IMMULITE 1000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |