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 2018-07-12 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[114039015]
This event occurred in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114039016]
The customer was evaluating the cobas e 411 immunoassay analyzer with 40 patient samples tested for elecsys rubella igg immunoassay (rubella igg) compared to 2 other unspecified clia instruments. Of the 40 patient samples, the results for 3 patient samples were false negative. On (b)(6) 2018 patient 1 result from the e411 analyzer was 3. 79 iu/ml (negative). The results from the unspecified clia instruments were 14. 5 (positive) and 15. 0 (positive). On (b)(6) 2018 patient 2 (female) result from the e411 analyzer was 7. 34 iu/ml (negative). The results from the unspecified clia instruments were 12. 0 (positive) and 10. 0 (positive). On (b)(6) 2018 patient 3 (female) result from the e411 analyzer was 6. 94 iu/ml (negative). The results from the unspecified clia instruments were 17. 2 (positive) and 15. 0 (positive). The 3 patient samples were also sent to an external laboratory where the positive rubella igg results were confirmed by the liaison method. The customer had reported the negative results outside of the laboratory. It is not clear which results were believed to be correct. This information was requested but was not provided. There was no allegation that an adverse event occurred. The e411 analyzer serial number was (b)(4). The customer's calibration signals were found to be constantly below the specified range. The patient samples are no longer available for investigation. Since sample material is not available, the investigation could not be completed. The investigation was unable to determine a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02251 |
| MDR Report Key | 7681008 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-12 |
| 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 | 2018-07-12 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 267421 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-07-12 |