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 2018-09-21 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[120982696]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120982697]
The customer complained of questionable elecsys rubella igg (rub igg) immunoassay results for 3 separate samples from the same patient tested on a cobas e 411 immunoassay analyzer compared to the results from the elisa igg test method. On (b)(6) 2018 sample a rub igg result from the cobas e411 was 19. 13 iu/ml, reactive. On (b)(6) 2018 sample b rub igg result from the cobas e411 was 19. 09 iu/ml, reactive. On (b)(6) 2018 sample c rub igg result from the cobas e411 was 16. 48 iu/ml, reactive. For samples a, b, and c the elisa igg test results were negative. The erroneous results were released outside of the laboratory to both the patient and their doctor. There was no allegation of an adverse event. The patient has no medical history of rubella disease or vaccination. The cobas e411 serial number was (b)(4). It was stated that the customer rarely runs qc testing. The customer had run qc testing on (b)(6) 2018 with acceptable results. From the information provided, it appears the rub igg reagent lot used for the (b)(6) 2018 result was lot 267421, and the rub igg reagent lot used for the (b)(6) 2018 results was lot 28366401 with an expiration date of 30-sep-2018.. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03222 |
| MDR Report Key | 7897455 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-21 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-09-04 |
| Date Added to Maude | 2018-09-21 |
| 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 | 2018-09-21 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 267421 |
| 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 | 2018-09-21 |