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 2016-12-05 for DIMENSION VISTA? K1021 SMN10445159 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[61497717]
The customer contacted the siemens customer care center (ccc). The account stated that the discrepant depressed bun results were obtained within one flex reagent cartridge well set. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[61497718]
The customer noted discrepant depressed bun qc and patient results on the dimension vista system. Patient samples were reported to the physician(s). The account repeated the patient samples on an alternate dimension vista instrument and higher results were obtained. There is no indication that patient treatment was altered or prescribed on the basis of discrepant bun results. There was no report of adverse health consequences as a result of discrepant bun results.
Patient Sequence No: 1, Text Type: D, B5
[66256814]
Siemens healthcare diagnostics headquarters support center (hsc) requested more information from the account to assist in the investigation. Hsc reviewed information provided by the customer for bun lot 16187ac flex sequence number 6737. Well number 6 of the flex reagent cartridge showed a low bias when compared to subsequent and previous wells. The customer stated that qc and patients were low when run from this one specific well. The customer stated that good qc and patient results were obtained using a different well. The customer has not complained of any further issues with bun. Hsc has not received any additional complaints of this nature for lot 16187ac. Based on the information provided, this was an isolated incident and the root cause cannot be determined with the information available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2016-00475 |
| MDR Report Key | 6146323 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-05 |
| Date of Report | 2017-01-25 |
| Date of Event | 2016-11-13 |
| Date Mfgr Received | 2017-01-10 |
| Device Manufacturer Date | 2016-07-05 |
| Date Added to Maude | 2016-12-05 |
| 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 |
| 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? BUN UREA NITROGEN FLEX? REAGENT CARTRIDGE |
| Product Code | CDQ |
| Date Received | 2016-12-05 |
| Catalog Number | K1021 SMN10445159 |
| Lot Number | 16187AC |
| Device Expiration Date | 2017-07-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-12-05 |