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 2019-04-15 for ELECSYS AMH SYSTEM 07957190190 manufactured by Roche Diagnostics.
[141990000]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141990001]
The initial reporter complained of high results not matching the clinical picture for 2 patients tested for elecsys amh plus (amh plus) on a cobas e 411 immunoassay analyzer. The high results were reported outside of the laboratory where the doctor stated the results were not possible. The customer noted that the patients were not taking the medication rekovelle. It is not clear how this relates to the questionable amh plus results. The customer suspects an interference affecting the results. There was no allegation that an adverse event occurred. The e411 analyzer serial number was (b)(4). The customer's calibration frequency is very low. The customer has not provided any qc data from the time of the patient results. The qc data that was provided shows very high results with suboptimal recovery. No issues were identified during a review of the alarm trace data. The customer uses 13 mm sample tubes with no rack adapters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01464 |
| MDR Report Key | 8514997 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-15 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-15 |
| 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 AMH SYSTEM |
| Generic Name | ANTI-M?LLERIAN HORMONE TEST SYSTEM |
| Product Code | PQO |
| Date Received | 2019-04-15 |
| Model Number | AMH |
| Catalog Number | 07957190190 |
| Lot Number | 329422 |
| 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 | 2019-04-15 |