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 2018-06-11 for ELECSYS IGE II IMMUNOASSAY 04827031190 manufactured by Roche Diagnostics.
[110708343]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[110708344]
The customer received a questionable high elecsys ige ii immunoassay result for one patient sample from modular e module serial number (b)(4). The initial result was 46888 iu/ml (>2500 undiluted) and was reported outside of the laboratory. The results for subsequent electrophoresis testing did not agree with this result as no increased immunoglobulin pattern was visible. Therefore, the sample was sent to another laboratory for confirmation. The result by a siemens method was 1002 iu/ml. The customer repeated an aliquot of the same sample on the modular e module and the results were >2500 undiluted and >50000 with an automatic dilution. There was no allegation of an adverse event. From analysis of the calibration and quality control data, a general reagent issue could be excluded. As no sample material was available, the investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01829 |
| MDR Report Key | 7586490 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-21 |
| Date Added to Maude | 2018-06-11 |
| 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 | 2018-06-11 |
| Model Number | IGE |
| Catalog Number | 04827031190 |
| Lot Number | 26628902 |
| ID Number | NA |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-06-11 |