MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-04 for ADVIA 120 manufactured by Siemens Healthcare Diagnostics, Inc..
[3173376]
The operator of the advia 120 instrument performed instrument maintenance and was injured during this procedure. The operator received a finger prick from the autosampler aspirate needle. The operator sought medical treatment and received antiviral medication at (b)(6) medical center. The operator has not received further injury or harm as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
[10551268]
A siemens field service engineer (fse) was dispatched to the customer site. The fse interviewed the operator, performed analysis of the instrument, instrument data, and samples. The fse determined that the cause of the operator injury was the operator's failure to adhere to the specified instrument maintenance procedures while cleaning the centering collar. The siemens operating guide indicates that "the operator should follow the recommendations to prevent the transmission of infectious agents in health-care settings as recommended for potentially infectious specimens in protection of laboratory workers from occupationally acquired infections; 3rd edition; approved guideline (2005) document m29-a3, clinical and laboratory standards institute (clsi) formally national committee for clinical laboratory standards). " further, "to void personal injury and exposure to a potential biohazard, you must cover the needle with the red needle cover immediately after you remove the centering collar. Be careful not to bend the needle as you slip the cover over it. " the operator did not cover the exposed needle during the maintenance procedure, also indicated in the maintenance instructions. The operator did not power off the instrument while cleaning the centering collar, as indicated in the maintenance instructions. The instrument is performing within specifications. The operator has not required additional medical attention due to the event. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00072 |
| MDR Report Key | 2988606 |
| Report Source | 05,06 |
| Date Received | 2013-03-04 |
| Date of Report | 2013-02-07 |
| Date of Event | 2013-02-07 |
| Date Mfgr Received | 2013-02-07 |
| Device Manufacturer Date | 2007-03-09 |
| Date Added to Maude | 2013-05-10 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNE MURPHY |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242619 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-03-04 |
| Model Number | ADVIA 120 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-04 |