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 2019-03-01 for ELECSYS VITAMIN D TOTAL II 07028148190 manufactured by Roche Diagnostics.
[137814666]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[137814667]
The customer questioned results for 13 patient samples tested for elecsys vitamin d total ii (vitamin d ii) on a cobas e 801 module. Based on the data provided, the results for 12 patient samples were discrepant. No erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). Roche diagnostics has issued an urgent medical device correction for this issue, entitled "elecsys? Vitamin d total ii assay? Non-reproducible false high results. " this correction has been reported to fda. During the implementation of the elecsys vitamin d total ii assay on the modular analytics e 170 module, and cobas e 601 and 602 systems, there were reports of non-reproducible, false high results. These customer observations were made in comparisons of duplicate measurements during assay validation of elecsys vitamin d total ii assay or in method comparisons with elecsys vitamin d assay (i. E. , during conversions), where the falsely elevated discrepant value did not fit the expected result. The observed elevated results reported with the elecsys vitamin d ii assay were not confirmed upon repeat testing of the affected samples. The observed findings: the first result is elevated, either above the upper end of the measuring range (>100 ng/ml or >250 nmol/ml), or within the measuring range; repeated results are significantly lower. Rare cases have been reported on the cobas e 411 analyzer and the cobas e 801 module. Roche is conducting investigations into the reported issue and has determined that the elecsys? Vitamin d total ii assay is strongly affected by pre-analytical errors. The investigations have reproduced these findings when requirements for pre-analytical sample handling have not been met for plasma samples. Further investigations into the reported issue are ongoing. As a result, the pre-analytical sample quality and compliance to the tube manufacturer? S specifications is very important to assure a high quality sample in order to minimize the risk of occurrence. Investigations are ongoing to determine the root cause of this issue. A workaround has been provided to customers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00819 |
| MDR Report Key | 8382961 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-01 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | RES 8008 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS VITAMIN D TOTAL II |
| Generic Name | VITAMIN D TEST SYSTEM |
| Product Code | MRG |
| Date Received | 2019-03-01 |
| Model Number | NA |
| Catalog Number | 07028148190 |
| Lot Number | 355684 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |