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 2019-04-02 for ELECSYS VITAMIN D TOTAL II manufactured by Roche Diagnostics.
[140621552]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[140621553]
The initial reporter stated that they have had ongoing issues with patient sample recovery for the elecsys vitamin d total gen. 2 assay on the cobas 6000 e 601 module. The customer provided data for 19 patient samples with erroneous vitamin d results. Refer to the attachment for all patient data. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The customer stated that they checked the reagents for bubbles prior to loading them on the analyzer. The serial number of the e 601 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01315 |
| MDR Report Key | 8472954 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-02 |
| Date of Report | 2019-06-13 |
| Date of Event | 2019-03-06 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-02 |
| 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 | 2019-04-02 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2019-04-02 |