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 2018-10-09 for ELECSYS VITAMIN B12 II 07212771190 manufactured by Roche Diagnostics.
[125291292]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[125291293]
The customer stated that an unknown number of samples collected from the same patient had erroneous results when tested with the elecsys vitamin b12 immunoassay on a cobas e 411 immunoassay analyzer. Erroneous values were reported outside of the laboratory. The specific date of the event was asked for, but not provided. All samples from the patient will result in values of < 50 pg/ml when tested on the e411 analyzer. The physicians state that the values do not agree with the clinical picture of the patient. When the samples are measured in another laboratory using an unknown method, the vitamin b12 results are normal. The customer believes that samples from the patient contain an interferent to a component of the vitamin b12 assay. The customer provided specific data for one sample from the patient. On (b)(6) 2018, this sample resulted with a value of < 50 pg/ml accompanied by a data flag when tested on the e 411 analyzer. This sample was centrifuged and repeated on (b)(6) 2018, resulting as < 50 pg/ml accompanied by a data flag on the e411 analyzer. This sample was tested in another laboratory using an unknown method, resulting as < 50 pg/ml. No adverse events were alleged to have occurred with the patient. There are no issues with the patient's blood count. The patient does not have anemia. The e 411 analyzer serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03479 |
| MDR Report Key | 7946423 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-09-19 |
| Date Added to Maude | 2018-10-09 |
| 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 B12 II |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2018-10-09 |
| Model Number | NA |
| Catalog Number | 07212771190 |
| Lot Number | 330955 |
| 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 | 2018-10-09 |