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 2017-04-21 for ELECSYS PROLACTIN ASSAY 03203093190 manufactured by Roche Diagnostics.
[73396550]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73396551]
The customer stated that a comparison study was performed showing high results for the elecsys prolactin assay (prl) and the elecsys dhea-s (dhea-s) assay on the cobas e 411 immunoassay analyzer (e411), when compared to results obtained from an immulite analyzer. Five patient samples for each assay were tested on the e411 at the customer's laboratory, and the immulite analyzer at another laboratory. This medwatch is for the prl results. Refer to medwatch with patient identifier (b)(6) for the dhea-s results. The customer stated that the high prl values do not fit the clinical pictures of the patients, he does not trust the values, and the immulite results fit the patients' clinical pictures better. It was requested, but unknown, whether any of the results were reported outside of the laboratory. However, the customer stated that in some cases, the high results have led to further unnecessary medical assessments for the patients. Refer to the attachment for all patient data. No adverse events were alleged to have occurred with the patients. The serial number of the e411 was requested but not provided. There was no general issue found with the reagent. The prl assay detects macroprolactin to a higher degree than some other assays on the market. There may be single samples recovering slightly differently between assays, and this is due to different specificity and sensitivity. Product labeling includes instructions for polyethylene glycol (peg) precipitation of macroprolactin that can be used in cases of implausibly high prl results.
Patient Sequence No: 1, Text Type: D, B5
[76647000]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00851 |
| MDR Report Key | 6511942 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-21 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-03-27 |
| Date Added to Maude | 2017-04-21 |
| 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 PROLACTIN ASSAY |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2017-04-21 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | ASKU |
| 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 | 2017-04-21 |