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 2019-02-11 for ELECSYS VITAMIN D TOTAL II 07028148190 manufactured by Roche Diagnostics.
[135871910]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[135871911]
The customer questioned results for 15 patient samples tested for elecsys vitamin d total ii (vitamin d total ii) on a cobas e 801 module. Based on the data provided the results for 11 patient samples were discrepant. The initial results were reported outside of the laboratory. The customer thinks the issue is related to one particular reagent pack. The customer repeated patient samples on a cobas 8000 e 602 module using the vitamin d total assay. The customer also repeated the patient samples on the e801 module in question using the vitamin d total ii assay. The customer then repeated the patient samples using a new reagent pack on the e602 module. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). The customer's maintenance was up to date. The measuring cell was last replaced in nov-2018. Liquid flow cleaning was last performed on 22-jan-2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00559 |
| MDR Report Key | 8327002 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-11 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-01-28 |
| Date Added to Maude | 2019-02-11 |
| 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 | 2019-02-11 |
| Model Number | NA |
| Catalog Number | 07028148190 |
| Lot Number | 35568400 |
| Device Expiration Date | 2019-08-31 |
| 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 | 2019-02-11 |