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 2019-04-09 for ELECSYS AFP ASSAY 04491742190 manufactured by Roche Diagnostics.
[141357846]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141357847]
The initial reporter stated that they received an erroneous result for one patient sample tested with the elecsys afp assay on a cobas 6000 e 601 module. The erroneous result was not reported outside of the laboratory. The sample initially resulted with an afp value of 7. 3 ng/ml. The customer then ran controls and these were outside of range. The customer tried re-calibrating, but calibration failed. The customer then placed a new reagent pack on the analyzer and repeated calibration, which passed. Controls were then tested and were acceptable. The sample was repeated using the new reagent pack and the result was 4. 7 ng/ml. No adverse events were alleged to have occurred with the patient. The serial number of the e 601 analyzer is (b)(4). The customer's refrigerator temperature was investigated and it was determined that the refrigerator temperature was approximately negative eleven degrees celsius for 8 hours. Per product labeling, the afp reagent should be stored at 2 - 8 degrees celsius and should not be frozen. The investigation could not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01398 |
| MDR Report Key | 8495828 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-03-24 |
| Date Mfgr Received | 2019-03-24 |
| Date Added to Maude | 2019-04-09 |
| 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 |
| 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 | 2019-04-09 |
| Model Number | NA |
| Catalog Number | 04491742190 |
| Lot Number | 34018900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-04-09 |