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 2018-02-01 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 07027770190 manufactured by Roche Diagnostics.
[99005275]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99005276]
The customer complained of discrepant results for 1 patient sample tested for elecsys rubella igg immunoassay (rubella igg) on a cobas e 801 module. The discrepant results are from 2 different reagent lots and the customer is not sure which result is correct as the patient was considered "immunized" using 1 reagent lot and "not immunized" from the other reagent lot. The customer also decided to reanalyze 20 samples from other patients on the 2 different reagent lots of rubella igg and one additional reagent lot of rubella igg. These samples were also sent to an external laboratory and tested by the siemens and blot method. Based on the data provided, the results for 11 patient samples were discrepant between the rubella igg reagent lots and the siemens and blot methods. This medwatch will cover rubella igg reagent lot 206165. Refer to medwatch with patient identifier (b)(6) for information on rubella igg reagent lot 267449 and medwatch with patient identifier (b)(6) for information on rubella igg reagent lot 282957. The patient had been tested on (b)(6) 2017 with reagent lot 206165 and the rubella igg result was 15 ui/ml (positive). When the patient was tested in (b)(6) 2018 with reagent lot 267449 the rubella igg result was 6. 56 ui/ml (negative). On (b)(6) 2018 the customer repeated the patient sample from (b)(6) 2017 using reagent lot 267449 and the result was 8. 23 ui/ml (negative). On (b)(6) 2018 the customer ran the patient sample from (b)(6) 2017 with reagent lot 267449 and the result was 8. 83 ui/ml (negative). No comparison results were provided for this sample. On (b)(6) 2018 the customer ran the patient sample from (b)(6) 2017 with reagent lot 267449 and the result was 7. 03 ui/ml (negative). No comparison results were provided for this sample. There was no allegation that an adverse event occurred. The e801 serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[117885150]
Based on the information available, a general reagent issue is not suspected. Product labeling comprehensively describes and addresses the issue of lot-to-lot variability and how to handle patient results that are close to the cut off. A product problem was not detected. The investigation was unable to find a definitive root cause for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00293 |
| MDR Report Key | 7233478 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-01 |
| Date of Report | 2018-03-19 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2018-02-01 |
| 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 | 2018-02-01 |
| Model Number | NA |
| Catalog Number | 07027770190 |
| Lot Number | 206165 |
| 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 | 2018-02-01 |