MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-01 for DIMENSION VISTA? K4014 SMN 10445121 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[58849279]
The customer contacted the siemens customer care center (ccc). The cause for the falsely depressed tobr results is unknown. The customer resolved the issue by recalibration. The customer has not had any additional discrepant patient results. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[58849280]
Falsely depressed tobramycin (tobr) results were obtained on two patient samples on the dimension vista 500 instrument. The results were reported to the physician. The same samples was repeated at an alternate laboratory (unknown instrument or methodology) and higher results were obtained. The customer stated that the repeated results matched the patients' clinical history. Corrected results were reported. There is no indication that patient treatment was altered or prescribed on the basis of the falsely depressed tobramycin (tobr) results. There was no report of adverse health consequences as a result of the falsely depressed tobramycin (tobr) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00345 |
| MDR Report Key | 6069438 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-01 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-10 |
| Device Manufacturer Date | 2016-04-12 |
| Date Added to Maude | 2016-11-01 |
| 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 | 3 |
| Event Location | 3 |
| 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 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? TOBR TOBRAMYCIN FLEX? REAGENT CARTRIDGE |
| Product Code | LCR |
| Date Received | 2016-11-01 |
| Catalog Number | K4014 SMN 10445121 |
| Lot Number | 16105AA |
| Device Expiration Date | 2017-04-14 |
| 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 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-01 |