MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-07 for ELECSYS PROLACTIN ASSAY 03203093190 manufactured by Roche Diagnostics.
[119657501]
Patient Sequence No: 1, Text Type: N, H10
[119657502]
The customer states that the roche platform has consistently higher results for patient samples tested with the elecsys prolactin assay when compared to prolactin results generated from competitor systems. The customer provided data for one patient sample with an erroneous prolactin result. When tested twice on a cobas 8000 e 602 module, the sample resulted with prolactin values of 39. 73 ng/ml and 40. 18 ng/ml. An erroneous value from the sample was reported outside of the laboratory and questioned by the physician. The sample was then sent to another laboratory for testing on a beckman system. When repeated on the beckman system, the sample resulted with a prolactin value of 29. 8 ng/ml. No adverse events were alleged to have occurred with the patient. The serial number of the e 602 analyzer is (b)(4). Based on a review of worldwide data of qc recovery for the reagent/calibrator lot combination used by the customer, no reagent issue was found. In cases of implausible high prolactin values, product labeling recommends sample precipitation by polyethylene glycol (peg) in order to estimate the amount of biological active monomeric prolactin. The customer does not use this pre-treatment procedure for sample testing. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03025 |
| MDR Report Key | 7855232 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-07 |
| 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 PROLACTIN ASSAY |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2018-09-07 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 29313001 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-09-07 |