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 2016-11-09 for ELECSYS AFP ASSAY 04491742190 manufactured by Roche Diagnostics.
[59577563]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[59577564]
The customer received questionable low elecsys afp assay results for one patient sample from cobas e602 analyzer serial number (b)(4). The results were 1. 93 ng/ml, 6. 00 ng/ml with a 1:10 dilution, and 2. 02 ng/ml as the previous result for the patient had been about 10,000 ng/ml, the customer tested another sample from the patient drawn at the same time as the suspect sample and the result was about 10,000 ng/ml. Information concerning if any result was reported outside the laboratory was requested, but it was unknown. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[61516766]
As part of the investigation, the sample from the patient that generated the result 2. 02 ng/ml of was tested and the customer's result was reproduced. Elecsys: 1. 83 ng/ml, lumipulse: 2. 2 ng/ml. Based on the data available, a specific root cause could not be determined. The sample does not have a non-specific reaction or prozone phenomenon. Additional sample was not available for further testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01752 |
| MDR Report Key | 6090305 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-09 |
| Date of Report | 2016-12-06 |
| Date of Event | 2016-10-29 |
| Date Mfgr Received | 2016-10-31 |
| Date Added to Maude | 2016-11-09 |
| 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 | 2016-11-09 |
| Model Number | NA |
| Catalog Number | 04491742190 |
| Lot Number | 120174 |
| 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 | 2016-11-09 |