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 2017-12-15 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[95939291]
(b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95939292]
The customer complained of 4 patient samples that tested negative for elecsys rubella igg (roche igg) immunoassay on cobas e 411 immunoassay analyzer were confirmed positive by western blot testing. The customer was contacted by a separate laboratory about a patient who tested negative for rubella igg using a roche method who was testing positive in their laboratory. The customer took all the sera samples that were found to be negative since (b)(6) 2016 and sent them to another laboratory for testing using diasorin method. Of 5 patient samples that were found to be negative, 4 were confirmed as being initially reported as false negatives and are a reportable malfunction. No specific units were provided. The diasorin cutoff is 12 while the roche igg cutoff is 10. The siemens cutoff was not provided. Patient #1 had a roche igg result of 6 (negative), a diasorin result of 35 (positive), a siemens result of 18, and a positive western blot. Patient #2 had a roche igg result of 6 (negative), a diasorin result of 23 (positive), a siemens result of 23, and a positive western blot. Patient #3 had a roche igg result of 3 (negative), a diasorin result of 32 (positive), a siemens result of 13. 7, and a positive western blot. Patient #4 had a roche igg result of 8 (negative), a diasorin result of <8 (negative), a siemens result of intermediate with an "ac anti-e1 positive", and a positive western blot. The patients were pregnant woman who all gave birth at the customer? S hospital. No other patient information was provided. The erroneous results were reported outside of the laboratory. The results from the western blot testing were deemed to be correct. There was no allegation of an adverse event. The cobas e411 serial (b)(4). The investigation is still ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02952 |
| MDR Report Key | 7120689 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-15 |
| Date of Report | 2018-01-04 |
| Date of Event | 2016-01-09 |
| Date Mfgr Received | 2017-11-30 |
| Date Added to Maude | 2017-12-15 |
| 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 | 2017-12-15 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 267421 |
| 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 | 2017-12-15 |