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 2018-03-28 for ELECSYS IGE II IMMUNOASSAY 04827031190 manufactured by Roche Diagnostics.
[103821339]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[103821340]
The customer received questionable elecsys ige ii immunoassay results for one patient from a roche diagnostics elecsys e170 modular analytics immunoassay analyzer. The serial number was requested but was not provided. On an unknown date, the first sample from the patient had a result of approximately 900 u/ml. This result was reported the to the patient. Some days later, the patient was redrawn and tested in another laboratory (emicap) and the result was approximately 10000 u/ml. On (b)(6) 2018, the patient was redrawn and tested on the roche diagnostics elecsys e170 modular analytics immunoassay analyzer. The result from a tube with gel was 765. 7 u/ml with a data flag and the result from a tube without gel was 865. 8 u/ml with a data flag. With a 1:20 dilution, the result was 9589 u/ml and with a 1:50 dilution, the result was 9828 u/ml. The result of 865. 8 u/ml with a data flag was reported outside of the laboratory. The result from the other laboratory was believed to be correct for the patient. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00925 |
| MDR Report Key | 7376739 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-28 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-03-07 |
| Date Added to Maude | 2018-03-28 |
| 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 | 2018-03-28 |
| Model Number | IGE |
| Catalog Number | 04827031190 |
| Lot Number | 266289 |
| 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 | 2018-03-28 |