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 2016-08-05 for DIMENSIONVISTA? SYSTEM K1021 SMN 10445159 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[51253913]
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 (umdc) dated february 2016, communication (b)(4) to all u. S accounts or an urgent field safety notice (b)(4), 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 (b)(4) and ufsn (b)(4) 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. The account acknowledged receipt of the umdc communication. In a umdc update information - resolution communication sent to the customers dated july 22, 2016, siemens healthcare diagnostics communicated that investigation indicates loss of activity of the gldh enzyme reagent from specific mold cavities caused the issue. Not all flexes or well sets are impacted. Siemens has implemented additional pre-release testing for all vista bun flex reagent lots. The additional testing ensures acceptable lot performance including gldh activity. Beginning with dimension vista bun flex lot 16110ac (expiration date 2017-04-19), and including all subsequent lots that expire thereafter, customers will no longer be required to follow directions in umdc letters (b)(4) or the corresponding urgent field safety notices (b)(4). The letter advised customers that once the laboratory has secured new inventory, they must discard older inventory. Starting with vista bun lot 16110ac, they may restore the normal use of vista bun flex reagent cartridges.
Patient Sequence No: 1, Text Type: N, H10
[51253914]
Discrepant bun patient results were obtained on the dimension vista(r) instrument. Patient results were reported to physicians. After qc was obtained outside of laboratory range, patient samples were repeated on an alternate bun flex cartridge and higher 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
| Report Number | 2517506-2016-00293 |
| MDR Report Key | 5849847 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-05 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-07-12 |
| Date Mfgr Received | 2016-07-12 |
| Device Manufacturer Date | 2016-02-02 |
| Date Added to Maude | 2016-08-05 |
| 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 |
| 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 | 2016-08-05 |
| Catalog Number | K1021 SMN 10445159 |
| Lot Number | 16033AC |
| Device Expiration Date | 2017-02-01 |
| 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 | 2016-08-05 |