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 2018-06-05 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[110125335]
Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[110125336]
The customer complained of questionable elecsys rubella igg immunoassay (rubella igg) results for 2 patient samples tested on a cobas 8000 e 602 module. For patient 1 the initial rubella igg result was 8 ui/ml, non reactive. The rubella igg result from another lot of reagent was 16 ui/ml, reactive. For patient 2 the initial rubella igg result was 8 ui/ml, non reactive. The rubella igg result from another lot of reagent was 16 ui/ml, reactive. The lot information for the other lot of rubella igg reagent was requested but was not provided. It was unknown if the erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The cobas e602 serial number was (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01751 |
| MDR Report Key | 7570407 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-05 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-05-18 |
| Date Added to Maude | 2018-06-05 |
| 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 | 2018-06-05 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 283664 |
| 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 | 2018-06-05 |