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 2018-03-29 for ELECSYS AFP ASSAY 04481798190 manufactured by Roche Diagnostics.
[104138880]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[104138881]
The customer complained of questionable high elecsys afp assay (afp) results for multiple patient samples on a cobas e 411 immunoassay analyzer serial number (b)(4). The customer stated that "every 10th-20th" sample with afp results 8-18 iu/ml were less than 5 iu/ml with a siemens immulite 2000 method. The customer provided data for 14 patient samples with erroneous afp results when compared to the siemens immulite 2000 method. The customer stated that most of the patients were males but did not provide the specific gender for each result. Refer to the attachment to this medwatch for all of the patient data. The erroneous results were reported outside of the laboratory however the physician was informed of the afp results with the siemens immulite 2000 method. There was no allegation of an adverse event. The customer poured the samples into eppendorf tubes and tested with "cup on tube". The customer did not have issues with other hormone tests.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00954 |
| MDR Report Key | 7381892 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-29 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-03-12 |
| Date Added to Maude | 2018-03-29 |
| 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 | ELECSYS AFP ASSAY |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2018-03-29 |
| Model Number | NA |
| Catalog Number | 04481798190 |
| Lot Number | 00300107 |
| ID Number | NA |
| Device Expiration Date | 2019-07-31 |
| 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 | 2018-03-29 |