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 2018-07-25 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[115277449]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[115277450]
The customer stated that they received erroneous results for one patient sample tested for the elecsys rubella igg immunoassay (rubigg) on a cobas 6000 e 601 module (e601). The sample initially resulted with an rubigg value of 33. 39 ui/ml (reactive). The rubella igm value from the sample was 0. 291 coi (non-reactive). Some days later, a sample from the patient was measured for rubella igg and rubella igm in a different laboratory and both test results were negative. On (b)(6) 2018, the original sample was repeated twice, resulting with rubigg values of 37. 08 ui/ml (reactive) and 35. 12 ui/ml (reactive). This sample was also tested with a rubella avidity assay manufactured by chorus-diesse on (b)(6) 2018 and this value was negative. No adverse events were alleged to have occurred with the patient. The serial number of the e601 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02458 |
| MDR Report Key | 7719401 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-25 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-07-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA |
| Product Code | LFX |
| Date Received | 2018-07-25 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 311042 |
| 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 | 2018-07-25 |