MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-28 for ELECSYS AFP ASSAY 04481798190 manufactured by Roche Diagnostics.
[118555951]
Patient Sequence No: 1, Text Type: N, H10
[118555952]
The customer stated that they received erroneous results for an unspecified number of samples from the same patient tested for the elecsys afp assay on a cobas 6000 e 601 module. The specific date of the event is not known. The customer stated that over a two year period, multiple samples from the patient recovered high afp results ranging between 761 and 1028 ng/ml when tested with multiple lots of the roche assay. When tested with the abbott and beckman coulter assays, the patient also had high values. The wako and siemens immulite platforms, however, yielded results from the patient which were within their respective normal reference ranges. The customer does not know which values are correct, but believes the high values to be in error. The customer suspects that samples from the patient contain an interferent to a component of the roche afp assay. The patient was not taking high levels of biotin. The customer provided data for two specific samples from the patient. No specific testing dates were provided for the two samples. The customer stated that the patient was last tested 2 to 3 months prior to (b)(6) 2018. The first sample resulted as 761 ng/ml when tested on the e601 analyzer. The value was reported outside of the laboratory and questioned by the doctor. The sample was sent to another laboratory for confirmation testing on the siemens immulite analyzer and the result was 3. 42 ng/ml, which was within the normal range of that assay. The customer then sent the patient sample to other laboratories for testing on additional platforms. The sample resulted with values of 1. 2 ng/ml and 3. 2 ng/ml when tested on the wako platform. When tested on an abbott system, the sample recovered 802 ng/ml, which is considered high. The sample also recovered a high value of 1162 ng/ml when tested on the beckman platform. The first sample was also aliquoted and the customer ran a dilution series on the customer's e601 analyzer using this aliquot. The sample was tested without dilution, resulting as 778. 4 ng/ml. A 1:1 dilution yielded a result of 355. 9 ng/ml. A 1:2 dilution of the sample yielded a result of 214. 2 ng/ml. A 1:4 dilution of the sample yielded a result of 124. 4 ng/ml. A 1:9 dilution of the sample yielded a result of 58. 41 ng/ml. A 1:1 dilution of the sample with mouse serum yielded a result of 337. 1. A second sample from the patient resulted as 938 ng/ml when tested on the e601 analyzer. The sample was treated with a heterophilic antibody blocking tube from scantibodies and then tested on the e601 analyzer, resulting with a value of 970 ng/ml. The patient was not adversely affected. The serial number of the e601 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02897 |
| MDR Report Key | 7822221 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-28 |
| Date of Report | 2018-10-29 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-28 |
| 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 | 2018-08-28 |
| Model Number | NA |
| Catalog Number | 04481798190 |
| Lot Number | ASKU |
| 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 | 2018-08-28 |