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 2018-01-04 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[97372425]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[97372427]
The customer received a questionable elecsys rubella igg immunoassay result for one patient sample. On (b)(6) 2017, the result was 13. 16 ui/ml(positive) and was reported outside of the laboratory. On (b)(6) 2017, the same sample was repeated with a new lot of reagent (267421) and the result was 8. 23 ui/ml (negative). There was no allegation of an adverse event. The customer used a cobas 6000 e 601 module. The serial number was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[131703826]
The reagent lot used at the time of the event was 267449. (b)(4). The investigation determined both rubella igg reagent lots performed within specification and the lot-to-lot variability was acceptable. A general reagent issue was not confirmed. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00042 |
| MDR Report Key | 7163245 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-04 |
| Date of Report | 2018-03-14 |
| Date of Event | 2017-10-09 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2018-01-04 |
| 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 | 2018-01-04 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 267449 |
| 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 | 2018-01-04 |