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 2019-03-18 for ELECSYS VITAMIN D TOTAL II 07464215160 manufactured by Roche Diagnostics.
[139084870]
Patient Sequence No: 1, Text Type: N, H10
[139084871]
The customer stated that they received erroneous results for two patient samples tested with the elecsys vitamin d total gen. 2 assay on a cobas 8000 e 602 module. The erroneous results were reported outside of the laboratory. The first sample initially resulted with a vitamin d value of > 100 ng/ml accompanied by a data flag. The sample was repeated, resulting with a value of 24 ng/ml. The second sample, from a (b)(6) female patient born on (b)(6), initially resulted with a vitamin d value of > 100 ng/ml accompanied by a data flag. The sample was repeated, resulting with a value of 29 ng/ml. The field service engineer checked the analyzer and determined there was a fluidics failure due to misadjustment of the mixer paddle. The engineer performed maintenance on the analyzer. Quality controls passed for other tests. After these service actions, the customer stated that the issue recurred and vitamin d data from a third patient sample was questioned. No adverse events were alleged to have occurred with the patients. The e 602 analyzer serial number is (b)(4). The field service engineer returned to the site and suspected the issue was related to the reagent pack. The reagent pack was replaced with a pack from a new lot number (lot 366706). The customer ran calibration and controls; all results passed and were within specifications. All further patient samples tested for vitamin d had no issues. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01117 |
| MDR Report Key | 8428891 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-18 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-18 |
| 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 | 2019-03-18 |
| Model Number | NA |
| Catalog Number | 07464215160 |
| Lot Number | 34014401 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2019-03-18 |