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 2018-05-09 for ELECSYS IGE II IMMUNOASSAY 07027516190 manufactured by Roche Diagnostics.
[108287643]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[108287644]
The customer complained of discrepant elecsys ige ii immunoassay results on a cobas 8000 e 602 module serial number (b)(4). Refer to the attachment to the medwatch for all patient data. The customer initially ran the sample on the e 602 analyzer with multiple dilutions. The customer complained the dilution results were not linear. The customer provided the sample for investigation where it was tested using the same dilutions. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01424 |
| MDR Report Key | 7500070 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-09 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-03-28 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-05-09 |
| 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 | ELECSYS IGE II IMMUNOASSAY |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) |
| Product Code | JHR |
| Date Received | 2018-05-09 |
| Model Number | NA |
| Catalog Number | 07027516190 |
| Lot Number | 266289 |
| ID Number | NA |
| Device Expiration Date | 2019-03-31 |
| 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 | 2018-05-09 |