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 2016-09-28 for DIMENSION VISTA K4089 SMN 10445139 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[55790107]
Analysis of the instrument and instrument data indicate that the cause for the falsely depressed csa result is unknown. Siemens headquarters support center has completed the investigation and determined that the qc failure matched the patient recovery failure for this date. The issue was resolved by repeat with a new calibration on an alternate lot. No returned sample or reagent was available for evaluation. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[55790108]
A falsely depressed cyclosporin a (csa) result was obtained on a patient sample on the dimension vista instrument. The result was not reported to the physician. The sample was repeated after an out of range qc result was observed. The sample was repeated and a higher result was obtained and reported. Patient treatment was not altered or prescribed on the basis of the falsely depressed (csa) result. There was no report of adverse health consequences as a result of the falsely depressed (csa) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00325 |
| MDR Report Key | 5982807 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-09-05 |
| Date Mfgr Received | 2016-09-08 |
| Device Manufacturer Date | 2016-03-15 |
| Date Added to Maude | 2016-09-28 |
| 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 | CYCLOSPORINE FLEX? REAGENT CARTRIDGE |
| Product Code | MKW |
| Date Received | 2016-09-28 |
| Catalog Number | K4089 SMN 10445139 |
| Lot Number | 16075AB |
| Device Expiration Date | 2017-03-15 |
| 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 | 2016-09-28 |