MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2016-03-29 for IMMUNOGLOBULIN E IGE 04827031190 manufactured by Roche Diagnostics.
[41425415]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41425416]
The customer complained of erroneous results for 1 patient sample tested for immunoglobulin e (ige ii). It is not known if erroneous results were reported outside of the laboratory. The initial ige ii result was 925. 00 iu/ml. The sample was diluted x5 and the result was >12,500. 00 iu/ml. The sample was diluted x400 and the result was 163,623. 00 iu/ml. No adverse event occurred. The e602 analyzer serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[45766373]
The patient sample was submitted for investigation. During the investigation the customer's results were reproduced. The very high ige ii results causes a high dose hook effect as described in product labeling. Based on the investigation data, a general reagent issue can be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00369 |
| MDR Report Key | 5532914 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2016-03-29 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-03-09 |
| Date Added to Maude | 2016-03-29 |
| 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 | 3 |
| Brand Name | IMMUNOGLOBULIN E |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) |
| Product Code | JHR |
| Date Received | 2016-03-29 |
| Model Number | IGE |
| Catalog Number | 04827031190 |
| Lot Number | 181429 |
| 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 | 2016-03-29 |