MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-31 for ELECSYS PROLACTIN ASSAY 03203093190 manufactured by Roche Diagnostics.
[71473700]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71473701]
The customer stated that comparison studies were performed showing consistent results for the elecsys prolactin assay (prl) on 3 different roche analyzers with higher results obtained with beckman and siemens analyzers. The customer is in the conversion phase and differences are seen in a selected patient cohort. The customer site is a hospital that provides care for newborn infants and women during pregnancy and child birth. The patient population may the higher amount of patients with higher than expected prolactin levels. None of the patient samples were collected from pregnant patients. Nine patient samples were tested using 2 cobas 8000 e 602 module (e602) analyzers, a cobas 6000 e 601 module, and a beckman coulter analyzer at the customer site. Twelve more patient samples were tested using the customer's e602 analyzer and a siemens analyzer for all 21 of these samples, erroneous results were reported outside of the laboratory to the doctor. The doctor expected to see results closer to recoveries on the beckman coulter and siemens analyzers. Approximately 70% of patient samples tested at the site show this behavior. Refer to the attachment for all patient data. No adverse events were alleged to have occurred with the patients. The serial number of the used e601 and e602 analyzers were asked for, but not provided. It is known that the elecsys prl assay recovers higher for specific patient samples than some other competitors like beckman and siemens. If a sample contains a high amount of macro-prolactin, it is recognized by the elecsys prl assay, generating a higher result compared to competitors. In addition, there may be always single samples recovering slightly different between methods and this is due to the different specificity and sensitivity. Product labeling instructs the customer to use polyethylene glycol precipitation on samples in case of implausible high prolactin values.
Patient Sequence No: 1, Text Type: D, B5
[72888952]
The customer's cohort does not seem to represent a normal patient population. Specific cohorts may reveal different prl levels than the normal population represented in product labeling. In special cohorts such as pregnant women, women after delivery, or infertility patients, the amount of macro-prolactin in their samples can be expected to be higher. Polyelthylene glycol precipitation of samples prior to testing is recommended in order to rule out the presence of macro-prolactin. The issue at the customer site is most likely caused by a higher recovery of specific sample cohorts. A general reagent issue is not likely.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00682 |
| MDR Report Key | 6449777 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-31 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-02-13 |
| Date Added to Maude | 2017-03-31 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2017-03-31 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 14357700 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| 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 | 2017-03-31 |