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 2019-04-23 for ELECSYS VITAMIN D TOTAL II 07028148190 manufactured by Roche Diagnostics.
[142768912]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[142768913]
The initial reporter stated that they received an erroneous high result for one patient sample tested with the elecsys vitamin d total gen. 2 assay on a cobas 8000 e 801 module. The erroneous result was not reported outside of the laboratory. The serum sample initially resulted with a vitamin d value of > 100 ng/ml. The sample was stored frozen and mixed prior to repeating. The sample was diluted times two and repeated, resulting with a value of 24 ng/ml. No adverse events were alleged to have occurred with the patient. The serial number of the e 801 analyzer is (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 | 1823260-2019-01559 |
| MDR Report Key | 8539309 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-23 |
| Date of Report | 2019-06-21 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-04-23 |
| 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 | 2019-04-23 |
| Model Number | NA |
| Catalog Number | 07028148190 |
| Lot Number | 355684 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-04-23 |