MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-30 for DIMENSION VISTA? K6420 SMN 10445097 manufactured by Siemens Healthcare Diagnostics Inc..
[125480210]
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant mass creatine kinase mb isoenzyme (mmb) results. Hsc determined that when the customer diluted the 2. 5 ng/ml sample with the 1:20 dilution, the recovered value of the instrument was less than 1 ng/ml which was below the value that could be accurately measured by the instrument. The system would then multiply the result by the dilution factor of 20; any recovered value of the diluted sample that is less than 1 ng/ml will give a value of < 20 ng/ml. The dilution protocol is developed for samples that are above assay range. The data does not show why the customer processed the initial samples with a dilution. A dilution was not triggered on the instrument, the dilution was manually entered by the operator. The discordant mmb result was due to the operator inappropriately ordering a dilution on the sample causing the < 20 ng/ml result. The customer did not report issues with any other assays on this instrument. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[125480212]
A discordant mass creatine kinase mb isoenzyme (mmb) result was obtained on a patient sample on the dimension vista system. The result was reported to the physician and was questioned. The same sample was reprocessed the same day and a correct result was obtained. A corrected report was issued. No treatment was provided to the patient on the basis of the reported discordant result. There are no known reports of patient intervention or adverse health consequences due to the discordant elevated mmb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00613 |
| MDR Report Key | 8018896 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-10 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2018-10-30 |
| 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 | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2018-10-30 |
| Catalog Number | K6420 SMN 10445097 |
| Lot Number | 18171BA |
| Device Expiration Date | 2019-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-30 |