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 2019-05-28 for ELECSYS AMH SYSTEM 07957190190 manufactured by Roche Diagnostics.
[146289911]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[146289912]
The initial reporter complained of questionable elecsys amh plus results for 1 patient tested on a cobas e 411 immunoassay analyzer and a cobas 8000 e 602 module. This medwatch will cover the questionable results on the e 411. Refer to medwatch with patient identifier (b)(6) for information on the questionable results on the e 602. On (b)(6) 2019 the amh result in a different laboratory on the e 602 was 27. 7 pmol/l. On (b)(6) 2019 the amh result on the e 411 was 10. 11 pmol/l. It was not known which result was believed to be correct. There was no allegation of an adverse event. No results were reported outside of the laboratory. The amh reagent lot number on the e 411 was 369817. The expiration date was not provided. The amh reagent lot number and expiration date used on the e 602 was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01985 |
| MDR Report Key | 8647530 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-28 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-06 |
| Date Added to Maude | 2019-05-28 |
| 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 |
| 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 | 2019-05-28 |
| Model Number | AMH |
| Catalog Number | 07957190190 |
| Lot Number | 369817 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-05-28 |