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 2019-05-01 for ELECSYS AFP ASSAY 04481798190 manufactured by Roche Diagnostics.
[143707357]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[143707358]
The initial reported complained of elecsys afp assay results for 1 patient from a cobas 6000 e 601 module that were not matching the patient's clinical picture. The initial afp result was >1000 iu/ml with a data flag. The patient sample was repeated using a 1:50 dilution and a result of 1329 iu/ml was obtained. A comparable result was also obtained for a siemens analyzer with an approximate afp result of 1800 iu/ml. The suspected high result was reported outside of the laboratory. There was no allegation of an adverse event. The customer believes these high results are not matching the patient's clinical finding as magnetic resonance imaging (mri) imaging was negative. The cobas e601 serial number was (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01615 |
| MDR Report Key | 8569513 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-05-01 |
| 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 |
| 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 | ELECSYS AFP ASSAY |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2019-05-01 |
| Model Number | AFP |
| Catalog Number | 04481798190 |
| Lot Number | 34949001 |
| 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 | 2019-05-01 |