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 2018-05-11 for RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS 04618793190 manufactured by Roche Diagnostics.
[108374512]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108374513]
The customer complained of false negative results for 1 patient tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 6000 e 601 module. On (b)(6) 2018 the patient was tested for rubella igg on the e601 module and the result was 5. 46 iu/ml (negative). This result was reported outside of the laboratory. On (b)(6) 2018 the patient went to another laboratory where a new sample was obtained. The rubella igg result from the immulite technic method as 21 iu/ml (positive) and the result from the diasorin method was 33 iu/ml (positive). On (b)(6) 2018 a new sample was obtained and the rubella igg result from the e601 module was 5. 26 iu/ml (negative). This sample was sent to an external laboratory where the result from the diasorin method was 38 iu/ml (positive) and the result from the abbott alinity method was 4 iu/ml (negative). The customer is not sure which results are correct. There was no allegation that an adverse event occurred. The e601 module serial number was (b)(4). The sample from (b)(6) 2018 was submitted for investigation. The rubella igg result at the investigation site was 5. 32 iu/ml(negative) which reproduced the customer's result. The rubella igg result seems to be plausible as the rubella igm result at the investigation site was also negative (0. 299). A reagent issue was not identified. The investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01450 |
| MDR Report Key | 7507667 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-11 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-11 |
| 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 | 2018-05-11 |
| Model Number | NA |
| Catalog Number | 04618793190 |
| Lot Number | 28366401 |
| 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 | 2018-05-11 |