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 2015-02-24 for IMMUNOGLOBULIN E 04827031190 manufactured by Roche Diagnostics.
[13000825]
A sample from the patient was investigated and the customer's results were confirmed. The patient was injected with xolair (omalizumab, anti-human ige antibody, novartis) for "rush oral immunotherapy. "
Patient Sequence No: 1, Text Type: N, H10
[13094524]
As part of the investigation, xolair was added to human ige samples and the results compared with a drug free control sample. The spiked samples showed reduced recovery of ige. A pharmacological interference with the assay was confirmed.
Patient Sequence No: 1, Text Type: N, H10
[13203570]
Additional information was provided concerning the patient. The patient's height was (b)(6). The patient was taking 300 mg/day of xolair once every two weeks from (b)(6) 2014 through current day.
Patient Sequence No: 1, Text Type: N, H10
[19769022]
The customer received questionable immunoglobulin (ige) results for one patient sample from an unknown roche analyzer. Original first result was 1701. 0 iu/ml, repeat result was 1799. 0 iu/ml. Auto dilution 1:5 result was 938. 4 iu/ml (calculated 4692. 0 iu/ml). Auto dilution 1:10 result was 509. 8 iu/ml (calculated 5098. 0 iu/ml). Manual dilution 1:50 result was 113. 8 iu/ml (calculated 5690 iu/ml). Information concerning which result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[19867300]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-01504 |
| MDR Report Key | 4542108 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-24 |
| Date of Report | 2015-04-15 |
| Date of Event | 2015-02-09 |
| Date Mfgr Received | 2015-02-10 |
| Date Added to Maude | 2015-02-24 |
| 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 | IMMUNOGLOBULIN E |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) |
| Product Code | JHR |
| Date Received | 2015-02-24 |
| Model Number | NA |
| Catalog Number | 04827031190 |
| Lot Number | 175624 |
| ID Number | NA |
| Device Expiration Date | 2015-07-30 |
| 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 | 2015-02-24 |