MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-01 for A1-FETOPROTEIN (AFP) 04481798190 manufactured by Roche Diagnostics.
[5833515]
The customer received questionable alpha1-fetoprotein (afp) results for one patient sample when compared to another methodology. The specific date of testing was not provided. The results from the cobas e601 analyzer serial number (b)(4) were 20- 21 ng/ml and were reproducible. These results did not match the patient's clinical condition. The result from a beckman access (unicell dxi) was <7 ng/ml. Information concerning which result was reported outside the laboratory was requested, but was not provided. No adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
[13407624]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[32500322]
A specific root cause could not be determined. Sample from the patient was tested as part of the investigation and the customer's results were reproduced and comparable on a cobas e411 and an abbott architect analyzer. As insufficient sample volume remained, no further investigation was possible. Differences in results between the two afp methods may be due to the different antibodies and technologies used. This information is documented in product labeling for the assay. Information was provided that the patient had a lung tumor. The use of the assay for monitoring of lung cancer patients is not an approved use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03554 |
| MDR Report Key | 4808592 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-05-13 |
| Date Added to Maude | 2015-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | A1-FETOPROTEIN (AFP) |
| Generic Name | ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2015-06-01 |
| Model Number | NA |
| Catalog Number | 04481798190 |
| Lot Number | ASKU |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-01 |