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 07464215190 manufactured by Roche Diagnostics.
[140621744]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[140621745]
The initial reporter stated that they noticed an issue with one reagent kit of the elecsys vitamin d total gen. 2 assay on the cobas 8000 e 602 module. An unspecified number of patient samples resulted with values of > 250 nmol/l and when repeated on another analyzer, results were within the technical limit of the assay. The customer provided data for a total of 36 patient samples and of these, one had an erroneous vitamin d result. The erroneous result was not reported outside of the laboratory. The sample initially resulted with a value of 88. 89 nmol/l when measured with the problematic kit. When tested on the other analyzer, the vitamin d result was 48. 98 nmol/l. No adverse events were alleged to have occurred with the patient. The e 602 analyzer serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01317 |
| MDR Report Key | 8472957 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-02 |
| Date of Report | 2019-09-23 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-15 |
| 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 | 07464215190 |
| Lot Number | ASKU |
| 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 |