MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-01 for VITAMIN B12 04745736190 manufactured by Roche Diagnostics.
[5835261]
The customer received questionable vitamin b12 results for one patient sample from a cobas e601 analyzer. The initial result on (b)(6) 2015 was <30 pg/ml with a data flag. On (b)(6) 2015 after freezing, the result with a 1:2 dilution was 3384 pg/ml. On (b)(6) 2015 after freezing, the result undiluted was <30 pg/ml with a data flag. With a 1:2 dilution, the result was 3358 pg/ml. The result of 3384 pg/ml was reported outside the laboratory. The result of <30 pg/ml was believed to be correct and a correction was sent. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[13355296]
The sample in question was submitted for further investigation. All results were within the assay measuring range and a dilution was not necessary. The customer's results were not reproduced. It was determined the dilution performed by the customer was not valid as the concentration of the sample must be >1000 pg/ml. A general reagent issue was excluded.
Patient Sequence No: 1, Text Type: N, H10
[13419416]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03562 |
| MDR Report Key | 4808978 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-05-15 |
| Date Added to Maude | 2015-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | VITAMIN B12 |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2015-06-01 |
| Model Number | NA |
| Catalog Number | 04745736190 |
| Lot Number | 183415 |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-01 |