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 2017-12-04 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[94847390]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94847391]
The customer complained of a false positive result for 1 pregnant patient tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 6000 e 601 module. It is unclear if the positive result was reported outside of the laboratory. On (b)(6) 2017 the patient had a rubella igg result on the e601 module of 24. 30 iu/ml (positive). On (b)(6) 2017 the patient had a rubella igg result on the e 601 module of 24. 29 iu/ml (positive). The sample from (b)(6) 2017 was tested by the siemens method and the result was 4. 43 iu/l (negative). The sample from (b)(6) 2017 was also tested by recomblot mikrogen and the conclusion was "traces" with a conclusion of uncertain presence of antibody. The patient is considered non-immune. There was no allegation that an adverse event occurred. The e601 module serial number was not provided. Samples from the patient were submitted for investigation. The customer? S results from the sample from (b)(6) 2017 and the sample from (b)(6) 2017 were reproduced with results of 25. 66 iu/ml (positive) and 22. 86 iu/ml (positive) respectively. Investigations are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02812 |
| MDR Report Key | 7078563 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-04 |
| Date of Report | 2018-02-06 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2017-12-04 |
| 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 | RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA |
| Product Code | LFX |
| Date Received | 2017-12-04 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 206194 |
| 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 | 2017-12-04 |