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 2018-09-19 for VALP VALPROIC ACID 20737933322 manufactured by Roche Diagnostics.
[120834238]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120834239]
The customer questioned results for 1 patient tested for valp valproic acid (valp) on a cobas integra 400 plus. The initial result was 345 ug/ml. The sample was diluted 1:2 and the result was 344 ug/ml. A new sample was obtained on (b)(6) 2018 and the result was 160 ug/ml. These results were believed to be too high. The customer suspects an interference. The results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The integra 400 plus serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03208 |
| MDR Report Key | 7890647 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-19 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-09-19 |
| 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 | VALP VALPROIC ACID |
| Generic Name | ENZYME IMMUNOASSAY, VALPROIC ACID |
| Product Code | LEG |
| Date Received | 2018-09-19 |
| Model Number | NA |
| Catalog Number | 20737933322 |
| 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 | 2018-09-19 |