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 2019-04-17 for ELECSYS VITAMIN D TOTAL II 07028148190 manufactured by Roche Diagnostics.
[142355312]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[142355313]
The initial reporter complained of discrepant results for 1 patient tested for vitamin d total (vitamin d) and elecsys vitamin d total ii (vitamin d ii) on a cobas 8000 e 602 module and a cobas e801 module. This medwatch will cover vitamin d ii. Refer to medwatch with patient identifier (b)(6) for information on the vitamin d results. The initial vitamin d ii result from the e801 module was 35. 9 ng/ml. The sample was repeated using vitamin d on the e602 module and the result was 3. 00 ng/ml. The customer re-centrifuged the sample and repeated it on the e602 module with a result of 6. 52 ng/ml. The customer performed a 1:2 dilution and repeated the sample on the e602 module with a result of 26. 7 ng/ml. The customer reported the vitamin d ii result of 35. 9 ng/ml outside of the laboratory. It is not clear which results the customer believes to be correct. A new sample was obtained from the patient on (b)(6) 2019 and the vitamin d ii result from the e801 module was 66. 5 ng/ml. The customer attempted to run this sample on the e602 module, however, an alarm message was received with no result. The customer observed a clot at the sipper probe. There was no allegation that an adverse event occurred. The e602 module serial number was (b)(4). The e801 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01525 |
| MDR Report Key | 8523560 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-17 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-17 |
| 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 | 2019-04-17 |
| Model Number | NA |
| Catalog Number | 07028148190 |
| 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 | 2019-04-17 |