MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for ELECSYS AMH SYSTEM 06331076190 manufactured by Roche Diagnostics.
[74638771]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[74638772]
The customer obtained a questionable result for one patient sample using the elecsys amh assay on the cobas e 411 immunoassay analyzer (e411). The result was 0. 162 ng/ml. This result was released outside of the laboratory. The physician considered this result inconsistent with the patient's clinical status. On an unspecified date, the patient had another amh result from another laboratory that was more consistent with the patient's clinical status. The result and laboratory method used were not provided. The sample was no longer available for testing. There was no allegation of an adverse event with the patient. The e411 serial number was not provided. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[75840471]
On an unspecified date, the patient had another amh result from another laboratory using a beckman-coulter method that was more consistent with the patient's clinical status. The result was 1. 65 ng/ml. The e411 serial number is (b)(4). On (b)(6) 2016, the patient had an amh result of 0. 410 ng/ml; an estradiol result of 301 pg/ml; and a progesterone result of 29. 90 ng/ml. On (b)(6) 2017, the patient had an estradiol result of 163 pg/ml. On (b)(6) 2017, the patient had an amh result of 1. 16 ng/ml and a tsh result of 0. 840 uiu/ml. The following is additional information: calibration was overdue by several months. Qc was acceptable on the date of the event. An assay performance check from september 2016 was within specifications. Based upon this information, a general reagent issue is not likely. A specific root cause could not be identified for this event. Additional information for further investigation was requested but was not provided. The most likely root cause is a non-reproducible, false low result due to poor sample quality (clots/fibrin or bubbles in the sample); sample mix-up; and/or insufficient maintenance. A recovery issue between the roche and beckman-coulter methods cannot be excluded, but is not very likely. The customer was advised to calibrate the instrument at the required frequency, and to monitor sample preparation and instrument handling processes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00948 |
| MDR Report Key | 6543632 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-04 |
| 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 | 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 | 2017-05-04 |
| Model Number | NA |
| Catalog Number | 06331076190 |
| Lot Number | 189115 |
| ID Number | NA |
| 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 | 2017-05-04 |