MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-01 for ELECSYS IGE II IMMUNOASSAY 04827031190 manufactured by Roche Diagnostics.
[76712961]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[76712962]
The customer received a questionable elecsys ige ii immunoassay result for one patient sample. The customer used cobas 8000 e 602 module serial number (b)(4). The initial result for this sample was 991. 7 iu/ml. The doctor did not agree with the result as it was not consistent with the medical history. This patient normally had a result of 21000 ui/ml. The customer performed dilutions of the sample as follows: 1:5 dilution result was 4569 iu/ml. A 1:10 dilution result was 12609 iu/ml. A 1:50 dilution result was 20333 iu/ml. A 1:100 dilution result was 21548 iu/ml. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[132595487]
Sample from the patient was submitted for investigation and an increased level of ige-igg complexes was detected. This most likely caused the reduced detection of ige in the undiluted sample. These complexes may result from an auto-immune disease and/or may be remnants of a terminated anti-allergy or anti-asthma therapy. Product labeling for the assay states not to use the assay for patients under treatment with xolair or similar drugs containing anti-ige antibodies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01123 |
| MDR Report Key | 6604794 |
| Date Received | 2017-06-01 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-01 |
| 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 | 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 | 0 |
| Brand Name | ELECSYS IGE II IMMUNOASSAY |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) |
| Product Code | JHR |
| Date Received | 2017-06-01 |
| Model Number | IGE |
| Catalog Number | 04827031190 |
| Lot Number | 17305400 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-01 |