MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-10 for SYVA? EMIT 6X019UL manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3111569]
Imprecise amikacin results were obtained on qc and a patient sample. The patient result was reported to the physician while qc was out of range. It is unknown if patient treatment was altered or prescribed. There is no report of adverse outcome to the patient as a result of imprecise amikacin result.
Patient Sequence No: 1, Text Type: D, B5
[10105319]
Analysis of the instrument and instrument data indicate that the cause for the imprecise amikacin results is unknown. Instrument data indicated that a patient result was reported while qc was outside of in-house ranges. Xamik is an open channel reagent (i. E. Flex prepared by customer). The dimension vista instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2012-00232 |
| MDR Report Key | 2736612 |
| Report Source | 05,06 |
| Date Received | 2012-09-10 |
| Date of Report | 2012-08-14 |
| Date of Event | 2012-08-13 |
| Date Mfgr Received | 2012-08-14 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-12-26 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYVA? EMIT |
| Generic Name | SYVA? EMIT AMIKACIN ASSAY |
| Product Code | KLQ |
| Date Received | 2012-09-10 |
| Catalog Number | 6X019UL |
| Lot Number | D2 |
| Device Expiration Date | 2014-08-31 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-10 |