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 2019-04-16 for ELECSYS VITAMIN D TOTAL II 07464215190 manufactured by Roche Diagnostics.
[142218130]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[142218131]
The initial reporter complained of high results not corresponding to the clinical picture for 1 patient sample tested for elecsys vitamin d total ii (vitamin d ii) on a cobas 6000 e 601 module. The initial vitamin d total ii result was > 100 ng/ml. The sample was repeated with a result of > 1000 ng/ml. The vitamin d total ii result using a 1:10 dilution was approximately 8000 ng/ml. This result was reported outside of the laboratory as > 1000 ng/ml where the doctor questioned the result. The customer ran the sample using vitamin d total and the result was 69 ng/ml. The customer repeated the sample using vitamin d total ii and the result was still above the technical range. There was no allegation that an adverse event occurred. The e601 module serial number was (b)(4). The customer stated qc results were within the acceptable range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01502 |
| MDR Report Key | 8519019 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-16 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-16 |
| 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 TOTAL II |
| Generic Name | VITAMIN D TEST SYSTEM |
| Product Code | MRG |
| Date Received | 2019-04-16 |
| Model Number | NA |
| Catalog Number | 07464215190 |
| Lot Number | 366696 |
| 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 | 2019-04-16 |