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 2018-11-13 for ELECSYS RUBELLA IGG IMMUNOASSAY 04618793190 manufactured by Roche Diagnostics.
[129159771]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129159772]
The customer stated that they received questionable results for one patient sample tested with the elecsys rubella igg immunoassay and the elecsys rubella igm immunoassay on a cobas 6000 e 601 module. Of the two tests, the sample had an erroneous rubella igg value that was reported outside of the laboratory to medical personnel treating the patient. The sample resulted with a positive rubella igg value when tested on the e 601 analyzer. The sample was sent to a reference laboratory where it was tested using an unknown method, resulting in a negative value. The patient returned to the customer site and had another sample tested. This sample also had a positive rubella igg value when tested on the e 601. No adverse events were alleged to have occurred with the patient. The e 601 analyzer serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04224 |
| MDR Report Key | 8064759 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-13 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-13 |
| 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 RUBELLA IGG IMMUNOASSAY |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA |
| Product Code | LFX |
| Date Received | 2018-11-13 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | ASKU |
| 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 | 2018-11-13 |