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 2017-12-22 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[96021813]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[96021814]
The customer received questionable elecsys rubella igg immunoassay results for three patients from cobas e 411 immunoassay analyzer (b)(4). Patient 1 initial result was 41. 21 iu/ml (positive) and the result was negative with the competitor system. Specific data could not be provided. On (b)(6) 2017, patient 2 initial result was 9. 20 iu/ml (negative) and the result was positive with the competitor system. Specific data could not be provided. Patient 3 initial result was 5. 72 iu/ml (negative) and the result was positive with the competitor system. Specific data could not be provided. The results were reported outside of the laboratory. There was no allegation of an adverse event. The provided calibration and qc data was within range. As no sample material was available for further investigation, a specific root cause could not be determined. Additional information for further investigation was requested but was not provided. Product labeling for the assay documents single false negatives/positives can occur due to the sensitivity/specificity of the assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-03118 |
| MDR Report Key | 7141669 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-22 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2017-12-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2017-12-22 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 26742101 |
| ID Number | NA |
| 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 | 2017-12-22 |