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 2015-02-03 for ELECSYS IGE II IMMUNOASSAY 04827031190 manufactured by Roche Diagnostics.
[12833409]
A specific root cause could not be identified as insufficient patient sample was available for further investigation. The testing excluded a linearity issue or a "hook effect" in the sample. Interference was suspected, but could not be confirmed. The provided analyzer performance data was within specification and did not indicate a specific issue.
Patient Sequence No: 1, Text Type: N, H10
[13095985]
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
[17267260]
The customer received questionable immunoglobulin e (ige) results for one patient sample. The original sample result was 1519. 0 iu/ml. The sample was tested with dilutions and the results were 6537. 0 iu/ml (1:5), 8183. 0 iu/ml (1:10) and 9156. 0 iu/ml (1:50). Information concerning which result was reported outside the laboratory was requested, but was not provided. There was no adverse event reported. The ige reagent lot number was 175624. The expiration date was requested, but was not provided. Sample from the patient was submitted for investigation and the customer's results were reproduced. Based on the provided calibration and qc data, a general reagent issue was excluded.
Patient Sequence No: 1, Text Type: D, B5
[17452602]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[17736330]
A new sample was drawn from the patient and the same phenomenon was observed. On (b)(6) 2015, the original immunoglobulin e (ige) result was 1511 iu/ml. With a 1:10 dilution, the result was 8313 iu/ml. This sample was submitted for further investigation. The patient was injected with "xolair (omalizumab, anti-human ige antibody, novartis)" for "rush oral immunotherapy. "
Patient Sequence No: 1, Text Type: N, H10
[22283789]
Additional information concerning the patient was provided. The patient's height was (b)(6). The patient was given 525 mg of xolair once every 2 weeks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00814 |
| MDR Report Key | 4479822 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2015-01-16 |
| Date Added to Maude | 2015-02-03 |
| 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 | ELECSYS IGE II IMMUNOASSAY |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) |
| Product Code | JHR |
| Date Received | 2015-02-03 |
| Model Number | NA |
| Catalog Number | 04827031190 |
| Lot Number | 175624 |
| 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 | 2015-02-03 |