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 2016-06-27 for DIMENSIONVISTA? SYSTEM K1021 SMN 10445159 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[48307866]
Siemens healthcare diagnostics has determined that dimension vista? Blood urea nitrogen (bun) lots 15215ae, 15243bb, 15264ba, 15299bb, 15300ba, 15320bb, and 15341ac may exhibit inaccurate patient and/or quality control results. Only specific reagent cartridge wells are affected. If calibration is performed using an unaffected well and patient results are subsequently run using an affected well, bun results may be falsely depressed by up to approximately 50%. If calibration is performed using an affected well, bun results may be falsely elevated by up to approximately 64%. Siemens issued an urgent medical device correction dated february 2016, communication vc-16. 01. B. Us to all u. S accounts or an urgent field safety notice vc-16-01. B. Ous, to all outside u. S. Accounts who had been shipped the impacted lots. Customers were directed to discard certain flexes with a specific lot number/cavity number combination. Siemens healthcare diagnostics confirmed additional complaints and has added additional blood urea nitrogen (bun k1021) lots 16004ab, 16034aa, 16033ac, 16048aa, 16055aa, 16055ab,16062aa, 16062ab as well as all future vista bun lots until further notice to the field action. An updated information communication umdc vc-16-01a. B. Us and ufsn vc-16-01a. B. Ous has been mailed in june 2016 to all accounts who have been shipped these lots. The communication advised customers to follow the additional instructions under the section "actions to be taken by the customer" to manage their bun testing.
Patient Sequence No: 1, Text Type: N, H10
[48307867]
Discrepant bun patient results were obtained on the dimension vista(r) instrument. Patient results were reported to physicians. The samples were repeated on an alternate dimension vista and revised results were obtained. Corrected results were reported. 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
[54919037]
Original mdr filed (b)(6) 2016. The mdr was filed for the complaint in relation to dimension vista? Blood urea nitrogen (bun) updated information communication umdc vc-16-01a. B. Us. The bun lot 16055ab is listed in that communication. Although the root cause of the outliers remains unknown, siemens headquarters service center evaluation of instrument data and service reports indicates that not all the results out of the suspect flex reagent cartridge well set gave discrepant results. The patient sample outliers occurred throughout the well set with several non-impacted samples within the same well set. Quality control recovery was within range before and after this well, however qc was not run on this specific well ((b)(6)). The customer had calibrated on the previous flex and a subsequent well on this flex. The readings all looked steady which would indicate there was not an impacted well. Based on the data provided, siemens remains unable to identify the root cause in this case. However, a customer service engineer was on site several times in the week after this event for various hardware failures. Since then there have been no further issues with discrepant bun results, it is suspected that the issue was resolved by service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2016-00257 |
| MDR Report Key | 5751031 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-27 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-07-12 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2016-06-27 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1622-2016 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSIONVISTA? SYSTEM |
| Generic Name | DIMENSION VISTA? UREA NITROGEN FLEX? REAGENT CARTRIDGE, |
| Product Code | CDQ |
| Date Received | 2016-06-27 |
| Catalog Number | K1021 SMN 10445159 |
| Lot Number | 16055AB |
| Device Expiration Date | 2017-02-23 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2016-06-27 |