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 2015-04-21 for AFP A1-FETOPROTEIN 04481798190 manufactured by Roche Diagnostics.
[18923274]
The customer questioned results for one patient sample tested for carcinoembryonic antigen (cea), afp a1-fetoprotein (afp) and hepatitis b surface antigen (hbsag). The results for cea and afp were erroneous. The erroneous results were reported outside of the laboratory where they were questioned by the physician. This medwatch will cover afp. Refer to medwatch with patient identifier (b)(6) for information on the cea erroneous results. The initial cea result was 16. 6 ng/ml. The sample was repeated after recentrifugation on (b)(6) 2015 and the cea result was 2. 61 ng/ml. The initial afp result was 16. 8 ng/ml. The sample was repeated after recentrifugation on (b)(6) 2015 and the afp result was 3. 97 ng/ml. No adverse event was reported. The e601 analyzer serial number was not provided. The field service engineer checked the analyzer and no problems were found. The analyzer and sample probe were cleaned. The pressure sensor was adjusted. The last calibration for afp was performed on (b)(6) 2014. Analyzer performance testing was completed with acceptable results.
Patient Sequence No: 1, Text Type: D, B5
[19064759]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21033382]
A specific root cause could not be identified. A general issue with the reagent or system can be excluded. Additional information for further investigation was requested but not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03158 |
| MDR Report Key | 4712831 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-05-28 |
| Date of Event | 2015-04-04 |
| Date Mfgr Received | 2015-04-10 |
| Date Added to Maude | 2015-04-21 |
| 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 | AFP A1-FETOPROTEIN |
| Generic Name | KIT,TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2015-04-21 |
| Model Number | NA |
| Catalog Number | 04481798190 |
| Lot Number | 178416 |
| ID Number | NA |
| Device Expiration Date | 2015-12-30 |
| 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 | 2015-04-21 |