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 2018-11-08 for ELECSYS VITAMIN D ASSAY 05894913190 manufactured by Roche Diagnostics.
[128420639]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[128420640]
The customer received questionable high vitamin d total results for one patient sample from cobas e411 rack analyzer serial number (b)(4). The result was repeatedly >70 ng/ml with a data flag while the calcium result was normal at 7. 8 mg/dl. These results were reported outside of the laboratory. The physician questioned the result as the vitamin d value should be increased or decreased in the same way as the calcium value. The physician suspected an interference with the assay. The customer sent the same sample to another laboratory using the vitamin d total reagent and the result was 90 ng/ml. There was no allegation of an adverse event. Qc results were in the acceptable range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04166 |
| MDR Report Key | 8052426 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-08 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2018-11-08 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS VITAMIN D ASSAY |
| Generic Name | VITAMIN D TEST SYSTEM |
| Product Code | MRG |
| Date Received | 2018-11-08 |
| Model Number | NA |
| Catalog Number | 05894913190 |
| Lot Number | 34167100 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-08 |