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.
[141991230]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141991231]
The initial reporter received questionable amh plus elecsys results for three patient samples from elecsys e170 modular analytics immunoassay analyzer serial number (b)(4). Patient 1 initial result was 1. 36 ng/ml and repeat result with another reagent lot was 1. 38 ng/ml. The sample was repeated on (b)(6) 2019 and the result was 0. 37 ng/ml. On (b)(6) 2019, patient 2 initial result was 0. 88 ng/ml and the repeat result with another reagent lot was 0. 82 ng/ml. The sample was repeated on (b)(6) 2019 and the result was 0. 42 ng/ml. On (b)(6) 2019, patient 3 initial result was 0. 50 ng/ml and the repeat result with another reagent lot was 0. 53 ng/ml. The sample was repeated on (b)(6) 2019 and the result was 0. 17 ng/ml. The results were reported outside of the laboratory. According to the doctor, these amh results were clinically unlikely. There was no allegation of an adverse event. The customer suspected an interference due to repeated freezing and thawing of the samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01465 |
| MDR Report Key | 8515051 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-15 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-02-28 |
| 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 | ASKU |
| 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 |