MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for ELECSYS PROLACTIN ASSAY PROLACTIN G2 manufactured by Roche Diagnostics.
[134461767]
The investigation stated the patient was taking very high dosages of biotin. The issue observed is consistent with interference caused by biotin intake. The patient sample was not available for further investigation, therefore, the cause of the event could not be determined. The investigation did not identify a product problem. The follow up/corrective action was that the sample was requested for investigation but could not be provided. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[134461768]
This report summarizes 1 malfunction event. Low results were generated by the cobas 8000 e 602 module. The event involved 1 patient with low results for the elecsys prolactin assay. The patient's age was requested, but was not provided. The patient's weight was requested, but was not provided. The patient's gender was requested, but was not provided. The patient's race was requested, but was not provided. The patient's ethnicity was requested, but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90042 |
| MDR Report Key | 8280772 |
| Date Received | 2019-01-28 |
| Date Added to Maude | 2019-01-28 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | SANDHOFFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), NA 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECSYS PROLACTIN ASSAY |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2019-01-28 |
| Model Number | PROLACTIN G2 |
| Lot Number | ASKU |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-01-28 |