MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for DIMENSION VISTA? K7062 SMN 10445905 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[69020661]
The cause of the imprecise urine malb results is user error. Starting with an incorrect entry of the method configuration digits of precision setting in (b)(6) 2016, the qc and patient results had been reporting with one digit of precision causing imprecise values. The dimension vista? System operator's guide chapter 9 advanced functions > method configuration section describes the settings for "fixed digits after decimal" and "digits of precision". This setting is method dependent. Examples are provided indicating how the value would be reported depending on the setting chosen. Such as with the malb issue reported, if "digits of precision" is set to 1, a result of 18 is reported as 20. A note is also listed: "it is recommended that digits of precision not be changed from the default settings in the software. " qc values remained within laboratory ranges during the period of incorrect setting. The digits of precision setting was corrected (b)(6) 2017. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[69020662]
A customer reported that imprecise microalbumin (malb) results were obtained on patient and qc urine samples during a period in which an incorrect digits of precision setting had been in use at the account. Patient results were reported during the period from july 2016 through the beginning of february 2017. Patient results were reported to physicians during the period. There is no indication that physicians questioned the results during the period. There was no known impact on patient treatment or care and no alleged patient harm due to the imprecise malb results during this period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00036 |
| MDR Report Key | 6368411 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2016-07-01 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2017-03-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? MALB MICROALBUMIN FLEX? REAGENT CARTRIDGE |
| Product Code | DCF |
| Date Received | 2017-03-01 |
| Catalog Number | K7062 SMN 10445905 |
| Lot Number | 16134MA |
| Device Expiration Date | 2017-11-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |